Trial Outcomes & Findings for A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer (NCT NCT03742102)
NCT ID: NCT03742102
Last Updated: 2026-04-24
Results Overview
The occurrence of a severe adverse event (meeting pre-specified criteria) that is at least possibly related to durvalumab and/or the novel oncology therapy in 6 DLT-evaluable patients
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
243 participants
Primary outcome timeframe
From the time of first dose until completion of the first cycle (28 days for Arms 2-5, 21 days for Arms 6-7 (no safety run-in for Arms 1 and 8))
Results posted on
2026-04-24
Participant Flow
Data cut-off is 30Jun23 for Arms 1,2,5,6 and 29Nov24 for Arms 7-8
Part 1 evaluated safety (with safety run-in Arms 2, 5, 6 and 7), efficacy, PK and immunogenicity for durvalumab combinations. Enrolment was expanded in Part 2, if pre-defined Part 1 efficacy signals were observed. Per the CSP and SAP, participants from Part 1 and 2 were analyzed together, no separate analyses by Part are available. Arms including Part 1 only: 1, 2, 5, 8. Arms including Part 1 and 2: Arms 6 and 7. No expansion to Part 2 was planned for Arm 8.
Participant milestones
| Measure |
Arm 1
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 2
Durvalumab 1500 mg q4w, IV + Paclitaxel 80 mg/m2 or 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off+ Capivasertib 400 mg, oral use bid 4 days on (D2, D3, D4, and D5) and 3 days off 4-week cycles: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 5
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off + Oleclumab 3000 mg q2w for first 2 cycles, IV (D1 and D15 of C1 and C2), then q4w starting at C3 (D1)
|
Arm 6
Durvalumab 1120 mg q3w, IV + Trastuzumab Deruxtecan 5.4 mg/kg q3w, IV
|
Arm 7
Durvalumab 1120 mg q3w, IV + Datopotamab Deruxtecan 6.0 mg/kg q3w, IV
|
Arm 8
Durvalumab 1120 mg q3w, IV + Datopotomab Deruxtecan 6.0 mg/kg q3w, IV (patients with PD-L1 positive status)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
31
|
33
|
58
|
62
|
33
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
23
|
31
|
33
|
58
|
56
|
30
|
Reasons for withdrawal
| Measure |
Arm 1
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 2
Durvalumab 1500 mg q4w, IV + Paclitaxel 80 mg/m2 or 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off+ Capivasertib 400 mg, oral use bid 4 days on (D2, D3, D4, and D5) and 3 days off 4-week cycles: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 5
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off + Oleclumab 3000 mg q2w for first 2 cycles, IV (D1 and D15 of C1 and C2), then q4w starting at C3 (D1)
|
Arm 6
Durvalumab 1120 mg q3w, IV + Trastuzumab Deruxtecan 5.4 mg/kg q3w, IV
|
Arm 7
Durvalumab 1120 mg q3w, IV + Datopotamab Deruxtecan 6.0 mg/kg q3w, IV
|
Arm 8
Durvalumab 1120 mg q3w, IV + Datopotomab Deruxtecan 6.0 mg/kg q3w, IV (patients with PD-L1 positive status)
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
14
|
17
|
25
|
22
|
28
|
3
|
|
Overall Study
Ongoing study at time of data cut-off (30Jun23 for Arms 1-6 and 29Nov24 for Arms 7-8)
|
8
|
9
|
5
|
33
|
24
|
25
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
3
|
2
|
3
|
2
|
|
Overall Study
Reason unknown
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=23 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 2
n=31 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 80 mg/m2 or 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off+ Capivasertib 400 mg, oral use bid 4 days on (D2, D3, D4, and D5) and 3 days off 4-week cycles: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 5
n=33 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off + Oleclumab 3000 mg q2w for first 2 cycles, IV (D1 and D15 of C1 and C2), then q4w starting at C3 (D1)
|
Arm 6
n=58 Participants
Durvalumab 1120 mg q3w, IV + Trastuzumab Deruxtecan 5.4 mg/kg q3w, IV
|
Arm 7
n=62 Participants
Durvalumab 1120 mg q3w, IV + Datopotamab Deruxtecan 6.0 mg/kg q3w, IV
|
Arm 8
n=33 Participants
Durvalumab 1120 mg q3w, IV + Datopotomab Deruxtecan 6.0 mg/kg q3w, IV (patients with PD-L1 positive status)
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52 Years
n=2 Participants
|
51 Years
n=1 Participants
|
54 Years
n=3 Participants
|
54 Years
n=24 Participants
|
53 Years
n=2 Participants
|
47 Years
n=2 Participants
|
52 Years
n=2 Participants
|
|
Sex/Gender, Customized
Female
|
23 Participants
n=2 Participants
|
31 Participants
n=1 Participants
|
33 Participants
n=3 Participants
|
58 Participants
n=24 Participants
|
62 Participants
n=2 Participants
|
33 Participants
n=2 Participants
|
240 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=2 Participants
|
31 Participants
n=1 Participants
|
33 Participants
n=3 Participants
|
56 Participants
n=24 Participants
|
62 Participants
n=2 Participants
|
33 Participants
n=2 Participants
|
238 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
8 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Asian
|
17 Participants
n=2 Participants
|
16 Participants
n=1 Participants
|
17 Participants
n=3 Participants
|
16 Participants
n=24 Participants
|
15 Participants
n=2 Participants
|
20 Participants
n=2 Participants
|
101 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=2 Participants
|
15 Participants
n=1 Participants
|
15 Participants
n=3 Participants
|
39 Participants
n=24 Participants
|
39 Participants
n=2 Participants
|
11 Participants
n=2 Participants
|
124 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
7 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: From the time of first dose until completion of the first cycle (28 days for Arms 2-5, 21 days for Arms 6-7 (no safety run-in for Arms 1 and 8))Population: Safety analysis set
The occurrence of a severe adverse event (meeting pre-specified criteria) that is at least possibly related to durvalumab and/or the novel oncology therapy in 6 DLT-evaluable patients
Outcome measures
| Measure |
Arm 1
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 2
n=6 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 80 mg/m2 or 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off+ Capivasertib 400 mg, oral use bid 4 days on (D2, D3, D4, and D5) and 3 days off 4-week cycles: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 5
n=6 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off + Oleclumab 3000 mg q2w for first 2 cycles, IV (D1 and D15 of C1 and C2), then q4w starting at C3 (D1)
|
Arm 6
n=6 Participants
Durvalumab 1120 mg q3w, IV + Trastuzumab Deruxtecan 5.4 mg/kg q3w, IV
|
Arm 7
n=6 Participants
Durvalumab 1120 mg q3w, IV + Datopotamab Deruxtecan 6.0 mg/kg q3w, IV
|
Arm 8
Durvalumab 1120 mg q3w, IV + Datopotomab Deruxtecan 6.0 mg/kg q3w, IV (patients with PD-L1 positive status)
|
|---|---|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT) Events
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments: every 8 wks (Arms 1-5) or every 6 wks (Arms 6-8) until wk 48, then every 12 wks from first IP dose until radiologic progression, death, withdrawal of consent, or study completion; up to max 54 mos (observed longest duration in Arm 1)Population: Number of patients with measurable disease at baseline who have had the opportunity to complete at least 2 on-treatment disease assessments
Percentage of evaluable patients with a confirmed Investigator-assessed response of CR (complete response) or PR (partial response). Confirmed response is defined as at least one visit response of CR or PR confirmed by a follow-up scan at least 4 weeks later showing CR or PR.
Outcome measures
| Measure |
Arm 1
n=23 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 2
n=31 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 80 mg/m2 or 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off+ Capivasertib 400 mg, oral use bid 4 days on (D2, D3, D4, and D5) and 3 days off 4-week cycles: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 5
n=33 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off + Oleclumab 3000 mg q2w for first 2 cycles, IV (D1 and D15 of C1 and C2), then q4w starting at C3 (D1)
|
Arm 6
n=58 Participants
Durvalumab 1120 mg q3w, IV + Trastuzumab Deruxtecan 5.4 mg/kg q3w, IV
|
Arm 7
n=62 Participants
Durvalumab 1120 mg q3w, IV + Datopotamab Deruxtecan 6.0 mg/kg q3w, IV
|
Arm 8
n=33 Participants
Durvalumab 1120 mg q3w, IV + Datopotomab Deruxtecan 6.0 mg/kg q3w, IV (patients with PD-L1 positive status)
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
56.5 Percentage of patients
Interval 34.5 to 76.8
|
54.8 Percentage of patients
Interval 36.0 to 72.7
|
51.5 Percentage of patients
Interval 33.5 to 69.2
|
62.1 Percentage of patients
Interval 48.4 to 74.5
|
79.0 Percentage of patients
Interval 66.8 to 88.3
|
81.8 Percentage of patients
Interval 64.5 to 93.0
|
SECONDARY outcome
Timeframe: Tumor assessments: every 8 wks (Arms 1-5) or every 6 wks (Arms 6-8) until wk 48, then every 12 wks from first IP dose until radiologic progression, death, withdrawal of consent, or study completion; up to max 54 mos (observed longest duration in Arm 1)Population: Full analysis set
Time from date of first dose (at least one study intervention \[durvalumab, paclitxel or novel oncology therapy\]) until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression)
Outcome measures
| Measure |
Arm 1
n=23 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 2
n=31 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 80 mg/m2 or 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off+ Capivasertib 400 mg, oral use bid 4 days on (D2, D3, D4, and D5) and 3 days off 4-week cycles: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 5
n=33 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off + Oleclumab 3000 mg q2w for first 2 cycles, IV (D1 and D15 of C1 and C2), then q4w starting at C3 (D1)
|
Arm 6
n=58 Participants
Durvalumab 1120 mg q3w, IV + Trastuzumab Deruxtecan 5.4 mg/kg q3w, IV
|
Arm 7
n=62 Participants
Durvalumab 1120 mg q3w, IV + Datopotamab Deruxtecan 6.0 mg/kg q3w, IV
|
Arm 8
n=33 Participants
Durvalumab 1120 mg q3w, IV + Datopotomab Deruxtecan 6.0 mg/kg q3w, IV (patients with PD-L1 positive status)
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
7.3 Months
Interval 5.4 to 11.3
|
6.4 Months
Interval 5.4 to 10.3
|
8.3 Months
Interval 4.8 to 9.3
|
12.6 Months
Interval 8.4 to 16.3
|
14.0 Months
Interval 11.0 to 21.1
|
11.2 Months
Interval 6.9 to 13.8
|
SECONDARY outcome
Timeframe: Tumor assessments: every 8 wks (Arms 1-5) or every 6 wks (Arms 6-8) until wk 48, then every 12 wks from first IP dose until radiologic progression, death, withdrawal of consent, or study completion; up to max 54 mos (observed longest duration in Arm 1)Population: Full analysis set
Time from the date of first documented response (which is subsequently confirmed) until the first date of documented progression (PD) or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1). If a patient does not progress following a response, then their DoR will be censored at the last evaluable disease assessment date
Outcome measures
| Measure |
Arm 1
n=23 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 2
n=31 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 80 mg/m2 or 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off+ Capivasertib 400 mg, oral use bid 4 days on (D2, D3, D4, and D5) and 3 days off 4-week cycles: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 5
n=33 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off + Oleclumab 3000 mg q2w for first 2 cycles, IV (D1 and D15 of C1 and C2), then q4w starting at C3 (D1)
|
Arm 6
n=58 Participants
Durvalumab 1120 mg q3w, IV + Trastuzumab Deruxtecan 5.4 mg/kg q3w, IV
|
Arm 7
n=62 Participants
Durvalumab 1120 mg q3w, IV + Datopotamab Deruxtecan 6.0 mg/kg q3w, IV
|
Arm 8
n=33 Participants
Durvalumab 1120 mg q3w, IV + Datopotomab Deruxtecan 6.0 mg/kg q3w, IV (patients with PD-L1 positive status)
|
|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
5.6 Months
Interval 3.75 to 26.12
|
7.9 Months
Interval 3.98 to 14.59
|
7.8 Months
Interval 5.42 to 17.77
|
15.2 Months
Interval 8.44 to
NA - Not calculable due to insufficient number of events for upper limit of confidence interval
|
17.6 Months
Interval 10.51 to 27.27
|
11.5 Months
Interval 5.16 to
NA - Not calculable due to insufficient number of events for upper limit of confidence interval
|
SECONDARY outcome
Timeframe: From date of first dose until date of death due to any cause; up to the maximum of 54 months (observed longest duration in Arm 1)Population: Full analysis set
Number of patients with overall survival, the time from date of first dose (at least one study intervention \[durvalumab, paclitxel or novel oncology therapy\]) until the date of death by any cause
Outcome measures
| Measure |
Arm 1
n=23 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 2
n=31 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 80 mg/m2 or 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off+ Capivasertib 400 mg, oral use bid 4 days on (D2, D3, D4, and D5) and 3 days off 4-week cycles: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 5
n=33 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off + Oleclumab 3000 mg q2w for first 2 cycles, IV (D1 and D15 of C1 and C2), then q4w starting at C3 (D1)
|
Arm 6
n=58 Participants
Durvalumab 1120 mg q3w, IV + Trastuzumab Deruxtecan 5.4 mg/kg q3w, IV
|
Arm 7
n=62 Participants
Durvalumab 1120 mg q3w, IV + Datopotamab Deruxtecan 6.0 mg/kg q3w, IV
|
Arm 8
n=33 Participants
Durvalumab 1120 mg q3w, IV + Datopotomab Deruxtecan 6.0 mg/kg q3w, IV (patients with PD-L1 positive status)
|
|---|---|---|---|---|---|---|
|
Overall Survival (Count)
Died
|
14 Participants
|
18 Participants
|
25 Participants
|
22 Participants
|
28 Participants
|
3 Participants
|
|
Overall Survival (Count)
Alive at data cut-off
|
8 Participants
|
9 Participants
|
5 Participants
|
33 Participants
|
30 Participants
|
28 Participants
|
|
Overall Survival (Count)
Terminated prior to death
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From date of first dose of IP until date of death due to any cause; up to the maximum of 54 months (observed longest duration in Arm 1)Population: Full analysis set
Time from date of first dose (at least one study intervention \[durvalumab, paclitxel or novel oncology therapy\]) until the date of death by any cause
Outcome measures
| Measure |
Arm 1
n=23 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 2
n=31 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 80 mg/m2 or 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off+ Capivasertib 400 mg, oral use bid 4 days on (D2, D3, D4, and D5) and 3 days off 4-week cycles: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 5
n=33 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off + Oleclumab 3000 mg q2w for first 2 cycles, IV (D1 and D15 of C1 and C2), then q4w starting at C3 (D1)
|
Arm 6
n=58 Participants
Durvalumab 1120 mg q3w, IV + Trastuzumab Deruxtecan 5.4 mg/kg q3w, IV
|
Arm 7
n=62 Participants
Durvalumab 1120 mg q3w, IV + Datopotamab Deruxtecan 6.0 mg/kg q3w, IV
|
Arm 8
n=33 Participants
Durvalumab 1120 mg q3w, IV + Datopotomab Deruxtecan 6.0 mg/kg q3w, IV (patients with PD-L1 positive status)
|
|---|---|---|---|---|---|---|
|
Overall Survival (Duration)
|
30.0 Months
Interval 13.0 to
NA - Not calculable due to insufficient number of events for upper limit of confidence interval
|
32.6 Months
Interval 12.9 to 40.0
|
24.8 Months
Interval 18.6 to 31.9
|
30.3 Months
Interval 18.8 to
NA - Not calculable due to insufficient number of events for upper limit of confidence interval
|
NA Months
Interval 23.2 to
NA - Not calculable due to insufficient number of events for upper limit of confidence interval
|
NA Months
NA - Not calculable due to insufficient number of events for upper limit of confidence interval
|
SECONDARY outcome
Timeframe: 6 months following date of first dosePopulation: Full analysis set
Percentage of patients alive and progression-free at 6 months following date of first dose (at least one study intervention \[durvalumab, paclitxel or novel oncology therapy\])
Outcome measures
| Measure |
Arm 1
n=23 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 2
n=31 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 80 mg/m2 or 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off+ Capivasertib 400 mg, oral use bid 4 days on (D2, D3, D4, and D5) and 3 days off 4-week cycles: 3 weeks on (D1, D8, and D15) and 1 week off
|
Arm 5
n=33 Participants
Durvalumab 1500 mg q4w, IV + Paclitaxel 90 mg/m2, IV, q4w: 3 weeks on (D1, D8, and D15) and 1 week off + Oleclumab 3000 mg q2w for first 2 cycles, IV (D1 and D15 of C1 and C2), then q4w starting at C3 (D1)
|
Arm 6
n=58 Participants
Durvalumab 1120 mg q3w, IV + Trastuzumab Deruxtecan 5.4 mg/kg q3w, IV
|
Arm 7
n=62 Participants
Durvalumab 1120 mg q3w, IV + Datopotamab Deruxtecan 6.0 mg/kg q3w, IV
|
Arm 8
n=33 Participants
Durvalumab 1120 mg q3w, IV + Datopotomab Deruxtecan 6.0 mg/kg q3w, IV (patients with PD-L1 positive status)
|
|---|---|---|---|---|---|---|
|
Progression-free Survival at 6 Months (PFS6)
|
56.5 Percentage of participants
Interval 34.3 to 73.8
|
52.4 Percentage of participants
Interval 33.1 to 68.5
|
65.3 Percentage of participants
Interval 46.0 to 79.1
|
75.2 Percentage of participants
Interval 61.8 to 84.5
|
79.8 Percentage of participants
Interval 67.2 to 88.0
|
78.2 Percentage of participants
Interval 59.5 to 89.0
|
Adverse Events
Durva + Pac
Serious events: 1 serious events
Other events: 22 other events
Deaths: 14 deaths
Durva + Pac + Capi 400mg Bid
Serious events: 11 serious events
Other events: 30 other events
Deaths: 18 deaths
Durva + Pac + Olec 3000mg
Serious events: 4 serious events
Other events: 32 other events
Deaths: 25 deaths
Durva + DS-8201a
Serious events: 16 serious events
Other events: 57 other events
Deaths: 22 deaths
Durva + Dato-DXd
Serious events: 18 serious events
Other events: 62 other events
Deaths: 28 deaths
Durva + Dato-DXd (PD-L1 High)
Serious events: 5 serious events
Other events: 33 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Durva + Pac
n=23 participants at risk
Description (Arm-group)
|
Durva + Pac + Capi 400mg Bid
n=31 participants at risk
Description (Arm-group)
|
Durva + Pac + Olec 3000mg
n=33 participants at risk
Description (Arm-group)
|
Durva + DS-8201a
n=58 participants at risk
Description (Arm-group)
|
Durva + Dato-DXd
n=62 participants at risk
Description (Arm-group)
|
Durva + Dato-DXd (PD-L1 High)
n=33 participants at risk
Description (Arm-group)
|
|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.3%
1/23 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
8.6%
5/58 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
General disorders
General physical health deterioration
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Covid-19
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Device related infection
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Empyema
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Mastitis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Pneumonia viral
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Sepsis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Urosepsis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Injury, poisoning and procedural complications
Flap necrosis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
Other adverse events
| Measure |
Durva + Pac
n=23 participants at risk
Description (Arm-group)
|
Durva + Pac + Capi 400mg Bid
n=31 participants at risk
Description (Arm-group)
|
Durva + Pac + Olec 3000mg
n=33 participants at risk
Description (Arm-group)
|
Durva + DS-8201a
n=58 participants at risk
Description (Arm-group)
|
Durva + Dato-DXd
n=62 participants at risk
Description (Arm-group)
|
Durva + Dato-DXd (PD-L1 High)
n=33 participants at risk
Description (Arm-group)
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.7%
2/23 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
3/31 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
13.8%
8/58 • Number of events 20 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
5.2%
3/58 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
5.2%
3/58 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
4/33 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
7/58 • Number of events 9 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
21.0%
13/62 • Number of events 16 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
4/33 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
5.2%
3/58 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
14.5%
9/62 • Number of events 11 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Endocrine disorders
Hyperthyroidism
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
10.3%
6/58 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
26.1%
6/23 • Number of events 15 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
3/31 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
24.2%
8/33 • Number of events 12 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
13.0%
3/23 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
4.8%
3/62 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Nervous system disorders
Dizziness
|
17.4%
4/23 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
15.2%
5/33 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.9%
8/62 • Number of events 14 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Nervous system disorders
Dysgeusia
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
4/33 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
16.1%
5/31 • Number of events 8 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
36.4%
12/33 • Number of events 13 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
15.5%
9/58 • Number of events 9 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
14.5%
9/62 • Number of events 17 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Nervous system disorders
Neuropathy peripheral
|
13.0%
3/23 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
19.4%
6/31 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
24.2%
8/33 • Number of events 9 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 8 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
56.5%
13/23 • Number of events 14 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
22.6%
7/31 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
39.4%
13/33 • Number of events 13 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Psychiatric disorders
Insomnia
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
16.1%
5/31 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
8.6%
5/58 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
11.3%
7/62 • Number of events 8 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
4/33 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Endocrine disorders
Hypothyroidism
|
26.1%
6/23 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
21.2%
7/33 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
25.9%
15/58 • Number of events 16 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
17.7%
11/62 • Number of events 11 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
24.2%
8/33 • Number of events 8 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
3/31 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
3/31 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
11.3%
7/62 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
3/23 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
25.8%
8/31 • Number of events 10 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
21.2%
7/33 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
10.3%
6/58 • Number of events 8 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
19.4%
12/62 • Number of events 13 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
18.2%
6/33 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
16.1%
5/31 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
8.1%
5/62 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
11.3%
7/62 • Number of events 9 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
15.2%
5/33 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Eye disorders
Dry eye
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
27.4%
17/62 • Number of events 17 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
4/33 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.9%
4/31 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
60.9%
14/23 • Number of events 14 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
35.5%
11/31 • Number of events 11 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
48.5%
16/33 • Number of events 16 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
27.6%
16/58 • Number of events 16 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
50.0%
31/62 • Number of events 33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
39.4%
13/33 • Number of events 14 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
5.2%
3/58 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
17.7%
11/62 • Number of events 11 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
21.7%
5/23 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Eye disorders
Keratitis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
16.1%
10/62 • Number of events 12 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.7%
5/23 • Number of events 9 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
32.3%
10/31 • Number of events 11 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
18.2%
6/33 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
5.2%
3/58 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
16.1%
10/62 • Number of events 12 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
18.2%
6/33 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Rash
|
39.1%
9/23 • Number of events 12 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
58.1%
18/31 • Number of events 27 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
27.3%
9/33 • Number of events 11 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
7/58 • Number of events 9 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
33.9%
21/62 • Number of events 30 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
39.4%
13/33 • Number of events 17 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.9%
4/31 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
11.3%
7/62 • Number of events 8 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
15.2%
5/33 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Vascular disorders
Flushing
|
8.7%
2/23 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Vascular disorders
Hot flush
|
8.7%
2/23 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
4/33 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Vascular disorders
Hypertension
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
8.1%
5/62 • Number of events 12 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Vascular disorders
Lymphoedema
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
5.2%
3/58 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Eye disorders
Lacrimation increased
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
11.3%
7/62 • Number of events 8 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Eye disorders
Limbal stem cell deficiency
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Eye disorders
Vision blurred
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
8.1%
5/62 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
15.2%
5/33 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Blood and lymphatic system disorders
Anaemia
|
8.7%
2/23 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
22.6%
7/31 • Number of events 11 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
4/33 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
27.6%
16/58 • Number of events 23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
14.5%
9/62 • Number of events 10 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Eye disorders
Visual impairment
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
1/23 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
3/31 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
6/62 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
10.3%
6/58 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Constipation
|
17.4%
4/23 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
15.2%
5/33 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
34.5%
20/58 • Number of events 26 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
50.0%
31/62 • Number of events 36 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
30.3%
10/33 • Number of events 12 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
3/23 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
67.7%
21/31 • Number of events 42 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
33.3%
11/33 • Number of events 15 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
22.4%
13/58 • Number of events 22 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
16.1%
10/62 • Number of events 26 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Dry mouth
|
8.7%
2/23 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
6/62 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Dyspepsia
|
17.4%
4/23 • Number of events 10 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
13.8%
8/58 • Number of events 9 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
6/62 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Gastritis
|
8.7%
2/23 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
5.2%
3/58 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
5.2%
3/58 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Nausea
|
47.8%
11/23 • Number of events 27 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
25.8%
8/31 • Number of events 11 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
33.3%
11/33 • Number of events 17 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
79.3%
46/58 • Number of events 71 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
67.7%
42/62 • Number of events 81 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
54.5%
18/33 • Number of events 30 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Stomatitis
|
17.4%
4/23 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.9%
4/31 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
18.2%
6/33 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
15.5%
9/58 • Number of events 11 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
69.4%
43/62 • Number of events 88 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
81.8%
27/33 • Number of events 35 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
4/23 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
3/31 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
31.0%
18/58 • Number of events 24 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
29.0%
18/62 • Number of events 42 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
27.3%
9/33 • Number of events 12 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
General disorders
Asthenia
|
17.4%
4/23 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
4/33 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
20.7%
12/58 • Number of events 16 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
11.3%
7/62 • Number of events 9 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
General disorders
Axillary pain
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
General disorders
Chest discomfort
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
General disorders
Fatigue
|
39.1%
9/23 • Number of events 13 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
32.3%
10/31 • Number of events 12 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
18.2%
6/33 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
53.4%
31/58 • Number of events 36 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
48.4%
30/62 • Number of events 46 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
36.4%
12/33 • Number of events 13 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
General disorders
Generalised oedema
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
General disorders
Influenza like illness
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
3/31 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
4.8%
3/62 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
General disorders
Oedema peripheral
|
30.4%
7/23 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
18.2%
6/33 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
General disorders
Pyrexia
|
17.4%
4/23 • Number of events 8 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
25.8%
8/31 • Number of events 15 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
13.8%
8/58 • Number of events 15 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
8.1%
5/62 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.0%
3/23 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
25.8%
8/31 • Number of events 29 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
32.8%
19/58 • Number of events 46 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
4.8%
3/62 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Covid-19
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
3/31 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
19.0%
11/58 • Number of events 12 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
24.2%
15/62 • Number of events 18 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Conjunctivitis
|
4.3%
1/23 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
15.5%
9/58 • Number of events 19 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Folliculitis
|
4.3%
1/23 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Lower respiratory tract infection
|
13.0%
3/23 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
2/23 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
6/62 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Tonsillitis
|
8.7%
2/23 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
2/23 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
4/33 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
13.8%
8/58 • Number of events 10 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.9%
8/62 • Number of events 16 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Infections and infestations
Urinary tract infection
|
13.0%
3/23 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
16.1%
5/31 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
5.2%
3/58 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
16.1%
10/62 • Number of events 16 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
6/62 • Number of events 17 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
4/33 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
Alanine aminotransferase increased
|
21.7%
5/23 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
16.1%
5/31 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
22.4%
13/58 • Number of events 17 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
11.3%
7/62 • Number of events 9 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
18.2%
6/33 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
Amylase increased
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.4%
2/58 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
19.4%
12/62 • Number of events 25 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
24.2%
8/33 • Number of events 11 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
Aspartate aminotransferase increased
|
13.0%
3/23 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
16.1%
5/31 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
20.7%
12/58 • Number of events 17 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
11.3%
7/62 • Number of events 9 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.1%
4/33 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
4.8%
3/62 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
8.6%
5/58 • Number of events 10 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
10.3%
6/58 • Number of events 13 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
4/62 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.9%
4/58 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
2/62 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
Lipase increased
|
8.7%
2/23 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
8.6%
5/58 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
Neutrophil count decreased
|
30.4%
7/23 • Number of events 28 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
12.9%
4/31 • Number of events 10 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.7%
1/58 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.1%
2/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
Platelet count decreased
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/31 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
5.2%
3/58 • Number of events 6 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
Weight decreased
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.2%
1/31 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
5.2%
3/58 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
6/62 • Number of events 7 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Investigations
White blood cell count decreased
|
4.3%
1/23 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
6.5%
2/31 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/58 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/62 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.4%
4/23 • Number of events 4 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.7%
3/31 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
9.1%
3/33 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
25.9%
15/58 • Number of events 17 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
21.0%
13/62 • Number of events 25 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
15.2%
5/33 • Number of events 5 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/23 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
32.3%
10/31 • Number of events 12 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
3.0%
1/33 • Number of events 2 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
5.2%
3/58 • Number of events 3 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
1.6%
1/62 • Number of events 1 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
0.00%
0/33 • From the time of signature of informed consent up to 90 days after the last dose of study treatment. If an event starts post this period noted and is considered to be due to a late-onset toxicity to study drug, then it should be reported as an AE/SAE. Maximum duration of approximately 54 months.
Arms 1-6 used MedDRA 26.0; Arms 7-8 used MedDRA 27.1
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place