Trial Outcomes & Findings for Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants (NCT NCT04484337)
NCT ID: NCT04484337
Last Updated: 2026-05-29
Results Overview
Blood samples were collected for Pharmacokinetic (PK) analysis of CAB. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
138 participants
Primary outcome timeframe
Injection 1 - Day 1 to Week 4
Results posted on
2026-05-29
Participant Flow
This study consisted of an Oral Lead In (OLI) Phase (day 1 to 28), an Injection Phase, which consisted of part 1 (cohorts 1-4h) and part 2 (cohort 5), and a Follow-up Phase up to 52 weeks.
Participant milestones
| Measure |
Part 1: Cohort 2 (C2) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 300 mg and Injection 2: 200 mg respectively) subcutaneously in the abdomen, 4 weeks apart, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Oral Cabotegravir (CAB) 30
Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.
|
Part 1: Cohort 1 (C1) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 1 (C1) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 2 (C2) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4 (C4) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 400 mg and Injection 2: 100 mg respectively), at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Oral Lead In (OLI) Phase
STARTED
|
0
|
138
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Oral Lead In (OLI) Phase
Not Randomized to Injection Phase
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Injection Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
5
|
0
|
|
Oral Lead In (OLI) Phase
Randomized to Injection Phase
|
0
|
125
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Oral Lead In (OLI) Phase
Withdrawn From Study After Randomization and Before Receiving an Injection
|
0
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Oral Lead In (OLI) Phase
COMPLETED
|
0
|
117
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Oral Lead In (OLI) Phase
NOT COMPLETED
|
0
|
21
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Injection Phase
STARTED
|
1
|
0
|
18
|
2
|
9
|
13
|
2
|
18
|
2
|
12
|
12
|
9
|
8
|
10
|
1
|
|
Injection Phase
COMPLETED
|
1
|
0
|
18
|
2
|
9
|
13
|
2
|
17
|
2
|
11
|
12
|
9
|
8
|
5
|
1
|
|
Follow-up Phase
STARTED
|
1
|
0
|
18
|
2
|
9
|
13
|
2
|
17
|
2
|
11
|
12
|
9
|
8
|
5
|
1
|
|
Follow-up Phase
COMPLETED
|
1
|
0
|
18
|
1
|
8
|
12
|
1
|
17
|
2
|
10
|
10
|
8
|
6
|
5
|
1
|
|
Follow-up Phase
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
0
|
0
|
1
|
2
|
1
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: Cohort 2 (C2) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 300 mg and Injection 2: 200 mg respectively) subcutaneously in the abdomen, 4 weeks apart, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Oral Cabotegravir (CAB) 30
Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.
|
Part 1: Cohort 1 (C1) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 1 (C1) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 2 (C2) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4 (C4) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 400 mg and Injection 2: 100 mg respectively), at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Oral Lead In (OLI) Phase
Withdrawal by Subject
|
0
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Oral Lead In (OLI) Phase
Physician Decision
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Oral Lead In (OLI) Phase
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Injection Phase
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Injection Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
|
Follow-up Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
1
|
0
|
0
|
|
Follow-up Phase
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Oral Cabotegravir (CAB) 30
n=13 Participants
Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.
|
Part 1: Cohort 1 (C1) CAB400
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 1 (C1) CAB200
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 2 (C2) CAB400
n=11 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 2 (C2) CAB200
n=1 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 300 mg and Injection 2: 200 mg respectively) subcutaneously in the abdomen, 4 weeks apart, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB200
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4 (C4) CAB200
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 400 mg and Injection 2: 100 mg respectively), at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=13 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=14 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=9 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
n=1 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Adult (18-64 years)
|
13 Participants
n=51 Participants
|
18 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
11 Participants
n=57 Participants
|
1 Participants
n=39 Participants
|
16 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
18 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=26 Participants
|
14 Participants
n=2 Participants
|
9 Participants
n=2 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
138 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=51 Participants
|
12 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
3 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
6 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=26 Participants
|
5 Participants
n=2 Participants
|
4 Participants
n=2 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
62 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
8 Participants
n=57 Participants
|
1 Participants
n=39 Participants
|
10 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=26 Participants
|
9 Participants
n=2 Participants
|
5 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
76 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
De-identified
|
11 Participants
n=51 Participants
|
17 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
11 Participants
n=57 Participants
|
1 Participants
n=39 Participants
|
16 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
15 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=26 Participants
|
13 Participants
n=2 Participants
|
8 Participants
n=2 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
128 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other, unspecified
|
2 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Injection 1 - Day 1 to Week 4Population: PK population included all participants in the Safety population (all participants who received at least one dose of study treatment (oral or injection)) who received study treatment and had at least 1 non-missing PK assessment (non-quantifiable \[NQ\] values will be considered as non-missing values). Only those participants with data available at specified time points have been analyzed. For Part 1: Cohort 3 (C3) CAB400 \[1\] group, 2 participants received 400 mg instead of 600 mg for Injection 1.
Blood samples were collected for Pharmacokinetic (PK) analysis of CAB. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=13 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 Injection 1: Time of Maximum Observed Plasma Concentration (Tmax) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b & 4h
Injection 1
|
197.731 Hour (h)
Standard Deviation 119.0789
|
150.215 Hour (h)
Standard Deviation 27.9825
|
122.009 Hour (h)
Standard Deviation 36.4273
|
145.648 Hour (h)
Standard Deviation 42.1305
|
206.228 Hour (h)
Standard Deviation 100.3655
|
137.853 Hour (h)
Standard Deviation 31.0810
|
131.833 Hour (h)
Standard Deviation 31.3543
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Injection 1: Time of Maximum Observed Plasma Concentration (Tmax) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b & 4h
Injection 1 [1]
|
—
|
—
|
132.575 Hour (h)
Standard Deviation 16.1574
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: Injection 2 - Day 1 to Week 52 follow-upPopulation: PK population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=11 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b
|
135.231 Hour (h)
Standard Deviation 39.8828
|
111.656 Hour (h)
Standard Deviation 36.9740
|
108.305 Hour (h)
Standard Deviation 25.7239
|
147.029 Hour (h)
Standard Deviation 35.9930
|
144.092 Hour (h)
Standard Deviation 89.0230
|
155.350 Hour (h)
Standard Deviation 45.5842
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Injection 1 - Day 1 to Week 12Population: PK population.
Blood samples were collected for PK analysis of CAB after intramuscular (IM) administration. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 Injection 1: Tmax for CAB 400 mg/ml Formulation for Cohort 5
|
163.093 Hour (h)
Standard Deviation 21.7123
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Injection 2 - Day 1 to Week 52 follow-upPopulation: PK population. There were no participants that received the second injection in C5.
Blood samples were collected for PK analysis of CAB after intramuscular (IM) administration. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Injection 2 - Week 4 to Week 52 follow-upPopulation: PK population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 Injection 2: Apparent Terminal Phase Half-life (T1/2) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b
|
451.4 Hour (h)
Geometric Coefficient of Variation 58.4
|
333.8 Hour (h)
Geometric Coefficient of Variation 51.1
|
375.1 Hour (h)
Geometric Coefficient of Variation 120.6
|
628.8 Hour (h)
Geometric Coefficient of Variation 84.7
|
2886 Hour (h)
Geometric Coefficient of Variation 42.0
|
645.0 Hour (h)
Geometric Coefficient of Variation 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Injection 2 - Week 12 to Week 52 follow-upPopulation: PK population. There were no participants that received the second injection in C5.
Blood samples were collected for PK analysis of CAB after intramuscular (IM) administration. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Injection 2 - Week 4 to Week 52 follow-upPopulation: PK population. Only those participants with data available at specified time points have been analyzed.
KALA defined as the rate at which a drug is absorbed into the bloodstream after administration. Blood samples were collected at indicated time points. PK parameters were determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 Injection 2: Terminal Absorption Elimination Rate Constant (KALA) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b
|
0.001535 1/h
Geometric Coefficient of Variation 58.4
|
0.002076 1/h
Geometric Coefficient of Variation 51.1
|
0.001847 1/h
Geometric Coefficient of Variation 120.6
|
0.001101 1/h
Geometric Coefficient of Variation 84.9
|
0.001376 1/h
Geometric Coefficient of Variation 94.3
|
0.001074 1/h
Geometric Coefficient of Variation 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Injection 2 - Week 12 to Week 52 follow-upPopulation: PK population. There were no participants that received the second injection in C5.
KALA defined as the rate at which a drug is absorbed into the bloodstream after administration. Blood samples were collected at indicated time points. PK parameters were determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Injection 1 - Day 1 to Week 4Population: PK population. Only those participants with data available at specified time points have been analyzed. In the "Part 1: Cohort 3 (C3) CAB400" group, 2 participants received 400 mg instead of 600 mg for Injection 1 \[1\].
Blood samples were collected for PK analysis of CAB. Ctau is the trough concentration at the end of the dosing interval. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze and compare the data for participants that received CAB 400 mg/ml formulation in this study, and historical data for CAB 200 mg/mL in ATLAS /FLAIR studies.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=6 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=11 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
n=501 Participants
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 Injection 1: Plasma Trough Concentrations (Ctau) of CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b & 4h
Injection 1
|
2.528 Microgram/ millilitre (μg/mL)
Geometric Coefficient of Variation 35.1
|
1.907 Microgram/ millilitre (μg/mL)
Geometric Coefficient of Variation 34.5
|
1.490 Microgram/ millilitre (μg/mL)
Geometric Coefficient of Variation 176.6
|
1.295 Microgram/ millilitre (μg/mL)
Geometric Coefficient of Variation 28.6
|
1.220 Microgram/ millilitre (μg/mL)
Geometric Coefficient of Variation 30.7
|
0.8572 Microgram/ millilitre (μg/mL)
Geometric Coefficient of Variation 46.6
|
1.371 Microgram/ millilitre (μg/mL)
Geometric Coefficient of Variation 43.5
|
1.382 Microgram/ millilitre (μg/mL)
Geometric Coefficient of Variation 71.7406
|
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Part 1 Injection 1: Plasma Trough Concentrations (Ctau) of CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b & 4h
Injection 1 [1]
|
—
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—
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0.8502 Microgram/ millilitre (μg/mL)
Geometric Coefficient of Variation 13.0
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PRIMARY outcome
Timeframe: Injection 2 - Day 1 to Week 4Population: PK population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis of CAB. Ctau is the trough concentration at the end of the dosing interval. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze and compare the data for participants that received CAB 400 mg/ml formulation in this study, and historical data for CAB 200 mg/mL in ATLAS /FLAIR studies.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=11 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=495 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 Injection 2: Ctau of CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b
|
2.853 μg/mL
Geometric Coefficient of Variation 40.0
|
1.333 μg/mL
Geometric Coefficient of Variation 60.4
|
1.542 μg/mL
Geometric Coefficient of Variation 51.6
|
1.290 μg/mL
Geometric Coefficient of Variation 31.0
|
1.590 μg/mL
Geometric Coefficient of Variation 26.9
|
1.646 μg/mL
Geometric Coefficient of Variation 34.8
|
1.840 μg/mL
Geometric Coefficient of Variation 49.3234
|
—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Injection 1 - Day 1 to Week 12Population: PK population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods. Ctau is the trough concentration at the end of the dosing interval. Ctau was expressed as geometric mean. For ATLAS /FLAIR: Historical data of CAB200 group, the geometric mean following dose normalization to 800mg was presented. The objective of this endpoint was to analyze and compare the data for participants that received CAB 400 mg/ml formulation in this study, and historical data for CAB 200 mg/mL in ATLAS /FLAIR and ECLAIRE studies.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=9 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=501 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=84 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 Injection 1: Ctau of CAB 400 mg/ml Formulation for Cohort 5
|
0.3787 μg/mL
Geometric Coefficient of Variation 79.7
|
1.843 μg/mL
Geometric Coefficient of Variation 71.7406
|
0.3024 μg/mL
Geometric Coefficient of Variation 157.1133
|
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PRIMARY outcome
Timeframe: Injection 1 - Day 1 to Week 4Population: PK population. Only those participants with data available at specified time points have been analyzed. In the "Part 1: Cohort 3 (C3) CAB400" group, 2 participants received 400 mg instead of the 600 mg for Injection 1 \[1\].
Blood samples were collected for PK analysis of CAB. The PK parameters were calculated by non-compartmental analysis. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=13 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 Injection 1: Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Time Point (AUC(0-t)) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b and 4h
Injection 1
|
2734 h*μg/mL
Geometric Coefficient of Variation 27.0
|
2640 h*μg/mL
Geometric Coefficient of Variation 30.2
|
2261 h*μg/mL
Geometric Coefficient of Variation 69.9
|
1510 h*μg/mL
Geometric Coefficient of Variation 42.9
|
1142 h*μg/mL
Geometric Coefficient of Variation 44.0
|
945.2 h*μg/mL
Geometric Coefficient of Variation 29.1
|
3133 h*μg/mL
Geometric Coefficient of Variation 18.4
|
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Part 1 Injection 1: Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Time Point (AUC(0-t)) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b and 4h
Injection 1 [1]
|
—
|
—
|
1583 h*μg/mL
Geometric Coefficient of Variation 10.4
|
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PRIMARY outcome
Timeframe: Injection 2 - Day 1 to Week 4Population: PK population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis of CAB. The PK parameters were calculated by non-compartmental analysis. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=11 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 Injection 2: AUC(0-t) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4 and 4b
|
4731 h*μg/mL
Geometric Coefficient of Variation 29.3
|
2050 h*μg/mL
Geometric Coefficient of Variation 51.6
|
3170 h*μg/mL
Geometric Coefficient of Variation 33.5
|
2417 h*μg/mL
Geometric Coefficient of Variation 30.9
|
2409 h*μg/mL
Geometric Coefficient of Variation 27.0
|
2649 h*μg/mL
Geometric Coefficient of Variation 24.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Injection 1 - Day 1 to Week 4Population: PK population. Only those participants with data available at specified time points have been analyzed. For Part 1: Cohort 3 (C3) CAB400 \[1\] group, 2 participants received 400 mg instead of the 600 mg for Injection 1.
The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=13 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 Injection 1: Maximum Observed Plasma Concentration (Cmax) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b and 4h
Injection 1
|
6.507 μg/mL
Geometric Coefficient of Variation 28.7
|
6.760 μg/mL
Geometric Coefficient of Variation 37.7
|
6.743 μg/mL
Geometric Coefficient of Variation 75.1
|
3.873 μg/mL
Geometric Coefficient of Variation 57.0
|
2.750 μg/mL
Geometric Coefficient of Variation 49.6
|
2.495 μg/mL
Geometric Coefficient of Variation 28.3
|
8.400 μg/mL
Geometric Coefficient of Variation 18.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Injection 1: Maximum Observed Plasma Concentration (Cmax) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b and 4h
Injection 1 [1]
|
—
|
—
|
6.541 μg/mL
Geometric Coefficient of Variation 7.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Injection 2 - Day 1 to Week 4Population: PK population. Only those participants with data available at specified time points have been analyzed.
The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=11 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 Injection 2: Cmax of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b
|
7.095 μg/mL
Geometric Coefficient of Variation 25.8
|
3.538 μg/mL
Geometric Coefficient of Variation 51.6
|
5.873 μg/mL
Geometric Coefficient of Variation 75.3
|
3.074 μg/mL
Geometric Coefficient of Variation 23.8
|
3.718 μg/mL
Geometric Coefficient of Variation 31.4
|
3.312 μg/mL
Geometric Coefficient of Variation 36.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Injection 1 day 1 up to 52 weeks follow-upPopulation: Safety population included all participants who received at least one dose of study treatment (oral or injection). In the "Part 1: Cohort 3 (C3) CAB400" group, 2 participants received 400 mg instead of 600 mg of CAB for Injection 1, therefore, the number of participants with AEs, for the 2 participants that received 400 mg of CAB for injection 1, is presented, separately, on "Injection 1 \[1\]" row in the below table.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The objective of this analysis is to present the data for participants that received at least an intramuscular or subcutaneous study injection of CAB 400 mg/mL or CAB 200 mg/mL with rHuPH20 formulation.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=9 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=13 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=9 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
n=8 Participants
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 and Part 2: Number of Participants With Adverse Events (AEs) in Injection Phase and Follow up Phase
Injection 1
|
17 Participants
|
9 Participants
|
11 Participants
|
18 Participants
|
12 Participants
|
12 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Adverse Events (AEs) in Injection Phase and Follow up Phase
Injection 1 [1]
|
—
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Adverse Events (AEs) in Injection Phase and Follow up Phase
Injection 2
|
15 Participants
|
8 Participants
|
10 Participants
|
16 Participants
|
12 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Adverse Events (AEs) in Injection Phase and Follow up Phase
Follow-up
|
3 Participants
|
2 Participants
|
5 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Injection 1 day 1 up to 52 weeks follow-upPopulation: Safety population included all participants who received at least one dose of study treatment (oral or injection). In the "Part 1: Cohort 3 (C3) CAB400" group, 2 participants received 400 mg instead of 600 mg of CAB for Injection 1, therefore, the number of participants with liver biochemistry abnormalities, for the 2 participants that received 400 mg of CAB for injection 1, is presented, separately, on "Injection 1 \[1\]" row, for each parameter analyzed, in the below table.
Blood samples were collected at indicated timepoints to analyze the liver biochemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), Bilirubin and Direct Bilirubin. The objective of this analysis is to present the data for participants that received at least an intramuscular or subcutaneous study injection of CAB 400 mg/mL or CAB 200 mg/mL with rHuPH20 formulation.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=9 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=13 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=9 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
n=8 Participants
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
AST, Injection 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
AST, Injection 1 [1]
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
AST, Injection 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
Bilirubin, Injection 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
Bilirubin, Injection 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
Bilirubin, Follow-up
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
Direct Bilirubin, Injection 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
ALT, Injection 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
ALT, Injection 1 [1]
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
ALT, Injection 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
ALT, Follow-up
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
ALP, Injection 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
ALP, Injection 1 [1]
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
ALP, Injection 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
ALP, Follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
AST, Follow-up
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
Bilirubin, Injection 1 [1]
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
Direct Bilirubin, Injection 1 [1]
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
Direct Bilirubin, Injection 2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase
Direct Bilirubin, Follow-up
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: PK population. Only those participants with data available at specified time points have been analyzed. The results for Oral Cabotegravir (CAB) 30 mg group includes those participants that received CAB during OLI phase but did not enter the injection phase (N=12)
Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=11 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=1 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
n=18 Participants
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=13 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=14 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=9 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
n=1 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for CAB Following Oral 30 mg Administration
|
3.728 μg/mL
Geometric Coefficient of Variation 19.6
|
3.921 μg/mL
Geometric Coefficient of Variation 15.3
|
5.007 μg/mL
Geometric Coefficient of Variation 8.1
|
4.526 μg/mL
Geometric Coefficient of Variation 18.0
|
4.090 μg/mL
Geometric Coefficient of Variation NA
Value is not calculable because there is only one participant in this group.
|
3.573 μg/mL
Geometric Coefficient of Variation 20.6
|
3.841 μg/mL
Geometric Coefficient of Variation 6.1
|
3.864 μg/mL
Geometric Coefficient of Variation 20.1
|
2.863 μg/mL
Geometric Coefficient of Variation 26.0
|
3.428 μg/mL
Geometric Coefficient of Variation 29.2
|
3.975 μg/mL
Geometric Coefficient of Variation 27.0
|
3.393 μg/mL
Geometric Coefficient of Variation 41.9
|
3.929 μg/mL
Geometric Coefficient of Variation 23.4
|
3.243 μg/mL
Geometric Coefficient of Variation 53.8
|
4.030 μg/mL
Geometric Coefficient of Variation NA
Value is not calculable because there is only one participant in this group.
|
SECONDARY outcome
Timeframe: Up to Day 29Population: PK population. Only those participants with data available at specified time points have been analyzed.The results for Oral Cabotegravir (CAB) 30 mg group includes those participants that received CAB during OLI phase but did not enter the injection phase (N=12).
Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=11 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=1 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
n=18 Participants
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=13 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=14 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=9 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
n=1 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for CAB Following Oral 30 mg Administration
|
1.9 Hour (h)
Geometric Coefficient of Variation 81.8
|
2.031 Hour (h)
Geometric Coefficient of Variation 58.9
|
1.000 Hour (h)
Geometric Coefficient of Variation NA
Value is not calculable.
|
1.957 Hour (h)
Geometric Coefficient of Variation 54.1
|
1.000 Hour (h)
Geometric Coefficient of Variation NA
Value is not calculable because there is only one participant in this group.
|
1.692 Hour (h)
Geometric Coefficient of Variation 67.6
|
2.000 Hour (h)
Geometric Coefficient of Variation 127.0
|
2.010 Hour (h)
Geometric Coefficient of Variation 54.1
|
1.732 Hour (h)
Geometric Coefficient of Variation 91.0
|
2.982 Hour (h)
Geometric Coefficient of Variation 58.3
|
1.528 Hour (h)
Geometric Coefficient of Variation 51.1
|
1.937 Hour (h)
Geometric Coefficient of Variation 55.7
|
2.113 Hour (h)
Geometric Coefficient of Variation 57.8
|
2.179 Hour (h)
Geometric Coefficient of Variation 78.0
|
1.067 Hour (h)
Geometric Coefficient of Variation NA
Value is not calculable because there is only one participant in this group.
|
SECONDARY outcome
Timeframe: Up to Day 29Population: PK population. Only those participants with data available at specified time points have been analyzed.The results for Oral Cabotegravir (CAB) 30 mg group includes those participants that received CAB during OLI phase but did not enter the injection phase (N=12).
Blood samples were collected for PK analysis of CAB after subcutaneous administration. The PK parameters were calculated by non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=11 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=1 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
n=18 Participants
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=13 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=14 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=9 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
n=10 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
n=1 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-t) for CAB Following Oral 30 mg Administration
|
50.725 h*μg/mL
Geometric Coefficient of Variation 18.1
|
60.91 h*μg/mL
Geometric Coefficient of Variation 19.7
|
69.29 h*μg/mL
Geometric Coefficient of Variation 1.7
|
70.31 h*μg/mL
Geometric Coefficient of Variation 17.2
|
60.62 h*μg/mL
Geometric Coefficient of Variation NA
Value is not calculable because there is only one participant in this group.
|
56.03 h*μg/mL
Geometric Coefficient of Variation 20.0
|
58.10 h*μg/mL
Geometric Coefficient of Variation 9.3
|
58.52 h*μg/mL
Geometric Coefficient of Variation 18.9
|
46.34 h*μg/mL
Geometric Coefficient of Variation 26.4
|
57.42 h*μg/mL
Geometric Coefficient of Variation 20.7
|
59.33 h*μg/mL
Geometric Coefficient of Variation 26.5
|
52.36 h*μg/mL
Geometric Coefficient of Variation 43.5
|
63.58 h*μg/mL
Geometric Coefficient of Variation 22.8
|
45.79 h*μg/mL
Geometric Coefficient of Variation 54.2
|
57.61 h*μg/mL
Geometric Coefficient of Variation NA
Value is not calculable because there is only one participant in this group.
|
SECONDARY outcome
Timeframe: At 24 hoursPopulation: PK population. Only those participants with data available at specified time points have been analyzed.The results for Oral Cabotegravir (CAB) 30 mg group includes those participants that received CAB during OLI phase but did not enter the injection phase (N=12)
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=18 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=11 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=1 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
n=18 Participants
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=13 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=14 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=9 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Concentration at 24 Hours (C24) for CAB Following Oral 30 mg Administration
|
1.5450422 μg/mL
Geometric Coefficient of Variation 19.3
|
1.971 μg/mL
Geometric Coefficient of Variation 20.6
|
2.125 μg/mL
Geometric Coefficient of Variation 1.0
|
2.229 μg/mL
Geometric Coefficient of Variation 16.7
|
1.760 μg/mL
Geometric Coefficient of Variation NA
Value is not calculable because there is only one participant in this group.
|
1.748 μg/mL
Geometric Coefficient of Variation 25.4
|
1.744 μg/mL
Geometric Coefficient of Variation 5.3
|
1.808 μg/mL
Geometric Coefficient of Variation 25.3
|
1.489 μg/mL
Geometric Coefficient of Variation 12.9
|
2.059 μg/mL
Geometric Coefficient of Variation 19.2
|
2.001 μg/mL
Geometric Coefficient of Variation 39.2
|
1.671 μg/mL
Geometric Coefficient of Variation 41.1
|
2.033 μg/mL
Geometric Coefficient of Variation 25.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 hours on day 29 (Oral lead in phase)Population: PK population. Only those participants with data available at specified time points have been analyzed.The results for Oral Cabotegravir (CAB) 30 mg group includes those participants that received CAB during OLI phase but did not enter the injection phase (N=12)
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=16 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=11 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=1 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=13 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
n=16 Participants
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
n=2 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=12 Participants
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=9 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ctau for CAB Following Oral 30 mg Administration
|
5.0488137 μg/mL
Geometric Coefficient of Variation 49.6
|
3.629 μg/mL
Geometric Coefficient of Variation 158.1
|
—
|
3.074 μg/mL
Geometric Coefficient of Variation 366.6
|
2.230 μg/mL
Geometric Coefficient of Variation NA
Value is not calculable because there is only one participant in this group.
|
5.456 μg/mL
Geometric Coefficient of Variation 42.2
|
3.576 μg/mL
Geometric Coefficient of Variation 23.7
|
5.430 μg/mL
Geometric Coefficient of Variation 44.3
|
4.468 μg/mL
Geometric Coefficient of Variation 3.8
|
4.169 μg/mL
Geometric Coefficient of Variation 76.0
|
4.667 μg/mL
Geometric Coefficient of Variation 31.9
|
4.811 μg/mL
Geometric Coefficient of Variation 51.1
|
6.966 μg/mL
Geometric Coefficient of Variation 59.3
|
3.596 μg/mL
Geometric Coefficient of Variation 60.5
|
—
|
SECONDARY outcome
Timeframe: Injection 1 - Day 1 to Week 52 follow-upPopulation: PK population.
Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of CAB 200 for Cohort 4h
|
2.507 μg/mL
Geometric Coefficient of Variation 29.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Injection 1 - Day 1 to Week 52 follow-upPopulation: PK population.
Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of CAB 200 for Cohort 4h
|
175.064 Hour (h)
Geometric Coefficient of Variation 41.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Injection 1 - Day 1 to Week 52 follow-upPopulation: PK population.
Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-t) of CAB 200 for Cohort 4h
|
3087 h*μg/mL
Geometric Coefficient of Variation 13.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Injection 1 - Day 1 to Week 52 follow-upPopulation: PK population.
Blood samples were collected for PK analysis of CAB after subcutaneous administration. Ctau is the trough concentration at the end of the dosing interval. PK parameter was determined using standard non-compartmental methods. Ctau was expressed as geometric mean. For ATLAS /FLAIR: Historical data of CAB200 group, the geometric mean following dose normalization to 400mg was presented.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=501 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ctau of CAB 200 for Cohort 4h and in ATLAS/FLAIR Study
|
1.008 μg/mL
Geometric Coefficient of Variation 36.6
|
0.9216 μg/mL
Geometric Coefficient of Variation 71.7406
|
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Injection 1 - Day 1 to Week 52 follow-upPopulation: PK population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis of CAB after subcutaneous administration. The PK parameters were calculated by non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=6 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
T1/2 of CAB 200 & CAB 400 for Cohort 4h
|
1233 Hour (h)
Geometric Coefficient of Variation 20.6
|
210.8 Hour (h)
Geometric Coefficient of Variation 42.0
|
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—
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—
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—
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SECONDARY outcome
Timeframe: Injection 1 - Day 1 to Week 52 follow-upPopulation: PK population. Only those participants with data available at specified time points have been analyzed.
KALA defined as the rate at which a drug is absorbed into the bloodstream after administration. Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=6 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 1: Cohort 2 (C2) CAB400
n=8 Participants
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
ATLAS /FLAIR: Historical Data of CAB200
Historical data from HIV-1 infected adult participants in Phase III studies ATLAS \[NCT02951052\] and FLAIR \[NCT02938520\] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 1: Cohort 4b Group 1 (C4b G1)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
KALA of CAB 200 & CAB 400 for Cohort 4h
|
0.0005615 1/h
Geometric Coefficient of Variation 20.6
|
0.003288 1/h
Geometric Coefficient of Variation 42.0
|
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—
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Adverse Events
Oral Cabotegravir (CAB) 30
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: Cohort 1 (C1) CAB400
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Part 1: Cohort 1 (C1) CAB200
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Cohort 2 (C2) CAB400
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 1: Cohort 2 (C2) CAB200
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Cohort 3 (C3) CAB400
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Part 1: Cohort 3 (C3) CAB200
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Cohort 4 (C4) CAB400
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Part 1: Cohort 4 (C4) CAB200
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Cohort 4b Group 1 (C4b G1)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Part 1: Cohort 4b Group 2 (C4b G2)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2: Cohort 5 (C5) CAB400
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 2: Cohort 5 (C5) CAB200
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Cabotegravir (CAB) 30
n=13 participants at risk
Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.
|
Part 1: Cohort 1 (C1) CAB400
n=18 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 1 (C1) CAB200
n=2 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 2 (C2) CAB400
n=11 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 2 (C2) CAB200
n=1 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 300 mg and Injection 2: 200 mg respectively) subcutaneously in the abdomen, 4 weeks apart, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=16 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB200
n=2 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=18 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4 (C4) CAB200
n=2 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 400 mg and Injection 2: 100 mg respectively), at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=13 participants at risk
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=14 participants at risk
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=9 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=8 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
n=10 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
n=1 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
Other adverse events
| Measure |
Oral Cabotegravir (CAB) 30
n=13 participants at risk
Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.
|
Part 1: Cohort 1 (C1) CAB400
n=18 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 1 (C1) CAB200
n=2 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 2 (C2) CAB400
n=11 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 2 (C2) CAB200
n=1 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 300 mg and Injection 2: 200 mg respectively) subcutaneously in the abdomen, 4 weeks apart, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB400
n=16 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 3 (C3) CAB200
n=2 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
|
Part 1: Cohort 4 (C4) CAB400
n=18 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4 (C4) CAB200
n=2 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 400 mg and Injection 2: 100 mg respectively), at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
|
Part 1: Cohort 4b Group 1 (C4b G1)
n=13 participants at risk
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
|
Part 1: Cohort 4b Group 2 (C4b G2)
n=14 participants at risk
Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
|
Part 1: Cohort 4h (C4h) CAB400 + rHuPH20
n=9 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
|
Part 1: Cohort 4h (C4h) CAB200 + rHuPH20
n=8 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
|
Part 2: Cohort 5 (C5) CAB400
n=10 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
|
Part 2: Cohort 5 (C5) CAB200
n=1 participants at risk
Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Cardiac disorders
Atrioventricular block first degree
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
27.3%
3/11 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
37.5%
6/16 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
77.8%
14/18 • Number of events 26 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
38.5%
5/13 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
35.7%
5/14 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
33.3%
3/9 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
60.0%
6/10 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
14.3%
2/14 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
27.8%
5/18 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site pain
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
18/18 • Number of events 32 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
2/2 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
72.7%
8/11 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
1/1 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
75.0%
12/16 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
2/2 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
94.4%
17/18 • Number of events 33 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
50.0%
1/2 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
92.3%
12/13 • Number of events 27 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
85.7%
12/14 • Number of events 24 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
9/9 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
8/8 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
10/10 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
1/1 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site nodule
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
55.6%
10/18 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
36.4%
4/11 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
1/1 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
50.0%
9/18 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
53.8%
7/13 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
35.7%
5/14 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
1/1 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site erythema
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
44.4%
8/18 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
50.0%
1/2 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
72.7%
8/11 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
25.0%
4/16 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
50.0%
1/2 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
18/18 • Number of events 26 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
50.0%
1/2 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
92.3%
12/13 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
85.7%
12/14 • Number of events 22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
9/9 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
8/8 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
40.0%
4/10 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site induration
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
33.3%
6/18 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
45.5%
5/11 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
18.8%
3/16 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
2/2 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
44.4%
8/18 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
50.0%
1/2 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
23.1%
3/13 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
14.3%
2/14 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site warmth
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
27.8%
5/18 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
18.8%
3/16 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
55.6%
10/18 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
92.3%
12/13 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
78.6%
11/14 • Number of events 18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
88.9%
8/9 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
75.0%
6/8 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
60.0%
6/10 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Fatigue
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
16.7%
3/18 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
15.4%
2/13 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
25.0%
2/8 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site swelling
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
36.4%
4/11 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
37.5%
6/16 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
55.6%
10/18 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
76.9%
10/13 • Number of events 18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
64.3%
9/14 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
77.8%
7/9 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
87.5%
7/8 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
70.0%
7/10 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Chills
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
16.7%
3/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
14.3%
2/14 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site bruising
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
50.0%
1/2 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site discomfort
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site oedema
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site pruritus
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
45.5%
5/11 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
25.0%
4/16 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
33.3%
6/18 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
53.8%
7/13 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
35.7%
5/14 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
77.8%
7/9 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
87.5%
7/8 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
18.8%
3/16 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
33.3%
6/18 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
15.4%
2/13 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
14.3%
2/14 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
16.7%
3/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
50.0%
1/2 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
50.0%
1/2 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Investigations
Lymph node palpable
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
16.7%
3/18 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
15.4%
2/13 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
33.3%
3/9 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
18.8%
3/16 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
22.2%
4/18 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
15.4%
2/13 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
2/16 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
16.7%
3/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
1/1 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
27.3%
3/11 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
23.1%
3/13 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
21.4%
3/14 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Oedema
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
2/16 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
16.7%
3/18 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Investigations
Body temperature increased
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
16.7%
3/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
6.2%
1/16 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
16.7%
3/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Catheter site bruise
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
50.0%
1/2 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Catheter site erythema
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Feeling cold
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Feeling hot
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Vaccination site pain
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
38.9%
7/18 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
2/18 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Investigations
White blood cell count increased
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
1/1 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Psychiatric disorders
Burnout syndrome
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteoma
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Vascular disorders
Hot flush
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
5.6%
1/18 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Application site plaque
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site discolouration
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
28.6%
4/14 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
50.0%
4/8 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site dryness
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site papule
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Malaise
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Skin and subcutaneous tissue disorders
Post inflammatory pigmentation change
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.7%
1/13 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Application site pruritus
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Application site rash
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Injection site exfoliation
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Vascular disorders
Flushing
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Axillary pain
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
General disorders
Administration site discolouration
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Infections and infestations
Otitis media
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Vascular disorders
Pallor
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
12.5%
1/8 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
0.00%
0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
100.0%
1/1 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 of OLI Phase up to approximately Week 52 of Follow-up Phase.
The adverse events were assessed based on overall treatment the participants received (only Oral CAB 30 mg tablets, or combination of Oral CAB 30 mg tablets + CAB injections). The participants with AEs that received only Oral CAB 30 and withdrew from the study prior to receiving any CAB injection were presented in Oral Cabotegravir (CAB) 30 group. The participants with AEs that received both Oral CAB 30 and CAB injection were presented in Part 1 and Part 2 groups of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER