Trial Outcomes & Findings for Trial of Pimasertib in Hematological Malignancies (NCT NCT00957580)
NCT ID: NCT00957580
Last Updated: 2017-08-21
Results Overview
The best overall response was to be reported as either of the following: (1) Morphologic complete remission (CR) = normalization of the peripheral blood absolute neutrophil count (PBANC) \>1.0x10\^9 per liter (/L), platelets \>100x10\^9 /L, bone marrow aspirate with less than or equal to (\<=) 5 percent (%) blasts, no blasts with Auer rods (AML only). (2) Complete remission with incomplete blood count recovery (CRi) = Same as CR without normalization of PBANC and platelet count. (3) Partial remission (PR) = normalization of PBANC \>1.0x10\^9/L, platelets \>100x10\^9/L, and at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts less than (\<) 5%. (4) Progressive disease (PD) = \>50% increase in peripheral blood or bone marrow blasts. (5) Stable disease (SD) = subjects who failed to achieve CR, CRi or PR and without criteria for PD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Day 29 of every 29-day cycle until progression reported between day of first subject randomized, September 2009, until cut-off date, December 2012
Results posted on
2017-08-21
Participant Flow
First/last subject (informed consent): September 2009/12 April 2012. Last subject completed : December 2012; Clinical data cut-off: December 2012.
Enrolled: 116 screened for eligibility; 35 were excluded (mainly non-fulfillment of inclusion or exclusion). 81 subjects were randomized.
Participant milestones
| Measure |
Regimen 1 (Part 1)
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
15
|
|
Overall Study
Treated
|
33
|
32
|
15
|
|
Overall Study
COMPLETED
|
33
|
31
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Regimen 1 (Part 1)
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|
|
Overall Study
Ongoing at data cut-off
|
0
|
1
|
0
|
|
Overall Study
Enrolled but not treated
|
0
|
1
|
0
|
Baseline Characteristics
Trial of Pimasertib in Hematological Malignancies
Baseline characteristics by cohort
| Measure |
Regimen 1 (Part 1)
n=33 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=32 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=15 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 to less than (<) 60
|
14 Subjects
n=99 Participants
|
12 Subjects
n=107 Participants
|
6 Subjects
n=206 Participants
|
32 Subjects
n=7 Participants
|
|
Age, Customized
60 to <75
|
13 Subjects
n=99 Participants
|
16 Subjects
n=107 Participants
|
6 Subjects
n=206 Participants
|
35 Subjects
n=7 Participants
|
|
Age, Customized
Greater than or equal to (>=) 75
|
6 Subjects
n=99 Participants
|
4 Subjects
n=107 Participants
|
3 Subjects
n=206 Participants
|
13 Subjects
n=7 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
51 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline Up to Day 29 of Cycle 1Population: The DLT analysis set included all subjects who received over 90 percent (%) administration of trial medication in Cycle 1 or showed a DLT.
The DLT was any toxicity that resulted in treatment delay for more than (\>) 2 weeks due to treatment-related adverse effects, or any Grade greater than or equal to (\>=) 3 non-hematological toxicity excluding Grade 4 asymptomatic increases in liver function tests reversible within 7 days in subjects with liver involvement, and Grade 3 asymptomatic increases in liver function tests reversible within 7 days for subjects without liver involvement, Grade 3 vomiting unless encountered and persistent for more than 3 days despite adequate and optimal therapy, and Grade 3 diarrhea unless encountered and persistent for more than 3 days despite adequate and optimal anti-diarrhea therapy at any DL and judged to be possibly or probably related to the trial treatment by the Investigator and/or the Sponsor.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=21 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=22 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=13 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Subjects With Dose Limiting Toxicities (DLTs)
|
1 subjects
|
0 subjects
|
5 subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29 of every 29-day cycle until progression reported between day of first subject randomized, September 2009, until cut-off date, December 2012Population: Due to limited anti-leukemic effects observed in the safety run-in part decision was made not to conduct part 2 hence this outcome measure was not assessed. Effects observed in the safety run-in part decision was made not to conduct part 2 hence this outcome measure was not assessed.
The best overall response was to be reported as either of the following: (1) Morphologic complete remission (CR) = normalization of the peripheral blood absolute neutrophil count (PBANC) \>1.0x10\^9 per liter (/L), platelets \>100x10\^9 /L, bone marrow aspirate with less than or equal to (\<=) 5 percent (%) blasts, no blasts with Auer rods (AML only). (2) Complete remission with incomplete blood count recovery (CRi) = Same as CR without normalization of PBANC and platelet count. (3) Partial remission (PR) = normalization of PBANC \>1.0x10\^9/L, platelets \>100x10\^9/L, and at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts less than (\<) 5%. (4) Progressive disease (PD) = \>50% increase in peripheral blood or bone marrow blasts. (5) Stable disease (SD) = subjects who failed to achieve CR, CRi or PR and without criteria for PD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 3 yearsPopulation: The safety analysis set included all the subjects who received at least one administration of the trial medication.
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs include both SAEs and non-SAEs.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=33 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=32 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=15 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Permanent Treatment Discontinuation
TEAEs Leading to Treatment Discontinuation
|
7 Subjects
|
7 Subjects
|
7 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Permanent Treatment Discontinuation
TEAEs
|
33 Subjects
|
32 Subjects
|
15 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Permanent Treatment Discontinuation
Serious TEAEs
|
24 Subjects
|
28 Subjects
|
12 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Permanent Treatment Discontinuation
TEAEs Leading to Death
|
6 Subjects
|
6 Subjects
|
5 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided adequate PK samples per protocol. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=6 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=7 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=9 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=4 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=19 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=10 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
n=4 Participants
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Plasma Concentration (Cmax) of Pimasertib Single Dose
|
14.8 nanogram/milliliter
Geometric Coefficient of Variation 43.0
|
29.3 nanogram/milliliter
Geometric Coefficient of Variation 32.0
|
59.1 nanogram/milliliter
Geometric Coefficient of Variation 86.2
|
132.8 nanogram/milliliter
Geometric Coefficient of Variation 29.6
|
151.6 nanogram/milliliter
Geometric Coefficient of Variation 38.8
|
207.0 nanogram/milliliter
Geometric Coefficient of Variation 27.8
|
269.9 nanogram/milliliter
Geometric Coefficient of Variation 46.1
|
241.9 nanogram/milliliter
Geometric Coefficient of Variation 81.0
|
342.6 nanogram/milliliter
Geometric Coefficient of Variation 18.5
|
SECONDARY outcome
Timeframe: Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3).Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided adequate PK samples per protocol. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=11 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=10 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=8 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=9 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=13 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=2 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=16 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=5 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
n=1 Participants
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Plasma Concentration (Cmax) of Pimasertib Multiple Dose
|
23.6 nanogram/milliliter
Geometric Coefficient of Variation 40.1
|
59.3 nanogram/milliliter
Geometric Coefficient of Variation 53.1
|
69.6 nanogram/milliliter
Geometric Coefficient of Variation 39.2
|
150.1 nanogram/milliliter
Geometric Coefficient of Variation 63.7
|
187.8 nanogram/milliliter
Geometric Coefficient of Variation 25.3
|
123.2 nanogram/milliliter
Geometric Coefficient of Variation 63.4
|
231.4 nanogram/milliliter
Geometric Coefficient of Variation 48.2
|
383.2 nanogram/milliliter
Geometric Coefficient of Variation 57.6
|
486.3 nanogram/milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not available as only 1 subject was evaluated for this group
|
SECONDARY outcome
Timeframe: Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples per protocol. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=7 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=7 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=9 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=4 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=19 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=10 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
n=4 Participants
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Time to Reach Maximum Plasma Concentration (Tmax): Single Dose
|
0.94 hour
Geometric Coefficient of Variation 41.18
|
2.25 hour
Geometric Coefficient of Variation 53.20
|
1.56 hour
Geometric Coefficient of Variation 151.73
|
1.09 hour
Geometric Coefficient of Variation 38.74
|
1.11 hour
Geometric Coefficient of Variation 78.05
|
1.12 hour
Geometric Coefficient of Variation 19.62
|
1.03 hour
Geometric Coefficient of Variation 40.27
|
2.70 hour
Geometric Coefficient of Variation 96.84
|
1.17 hour
Geometric Coefficient of Variation 76.62
|
SECONDARY outcome
Timeframe: Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples per protocol. Number of subjects analysed refer to the subjects evaluable for this outcome measure.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=11 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=10 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=8 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=9 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=13 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=2 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=16 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=5 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
n=1 Participants
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Time to Reach Maximum Plasma Concentration (Tmax): Multiple Dose
|
1.44 hour
Geometric Coefficient of Variation 78.61
|
1.75 hour
Geometric Coefficient of Variation 83.12
|
2.03 hour
Geometric Coefficient of Variation 59.04
|
1.99 hour
Geometric Coefficient of Variation 70.40
|
1.64 hour
Geometric Coefficient of Variation 73.93
|
1.41 hour
Geometric Coefficient of Variation 52.11
|
1.78 hour
Geometric Coefficient of Variation 112.59
|
2.75 hour
Geometric Coefficient of Variation 21.83
|
2.00 hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not available as only 1 subject was evaluated for this group.
|
SECONDARY outcome
Timeframe: Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.
The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=4 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=6 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=7 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=8 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=4 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=18 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=5 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
n=3 Participants
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Terminal Half-Life (t1/2) of Pimasertib: Single Dose
|
5.28 hour
Geometric Coefficient of Variation 41.55
|
3.52 hour
Geometric Coefficient of Variation 19.75
|
3.05 hour
Geometric Coefficient of Variation 13.96
|
4.01 hour
Geometric Coefficient of Variation 36.61
|
3.88 hour
Geometric Coefficient of Variation 42.26
|
3.45 hour
Geometric Coefficient of Variation 23.80
|
2.97 hour
Geometric Coefficient of Variation 21.92
|
4.21 hour
Geometric Coefficient of Variation 92.04
|
3.39 hour
Geometric Coefficient of Variation 49.59
|
SECONDARY outcome
Timeframe: Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3).Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.
The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=7 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=6 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=6 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=11 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=2 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=11 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=2 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
n=1 Participants
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Terminal Half-Life (t1/2) of Pimasertib: Multiple Dose
|
6.97 hour
Geometric Coefficient of Variation 75.47
|
10.91 hour
Geometric Coefficient of Variation 590.54
|
3.69 hour
Geometric Coefficient of Variation 22.69
|
3.93 hour
Geometric Coefficient of Variation 32.17
|
3.71 hour
Geometric Coefficient of Variation 21.38
|
3.96 hour
Geometric Coefficient of Variation 17.24
|
4.52 hour
Geometric Coefficient of Variation 66.99
|
8.44 hour
Geometric Coefficient of Variation 175.10
|
5.04 hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not available as only 1 subject was evaluated for this group
|
SECONDARY outcome
Timeframe: Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=6 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=7 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=9 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=4 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=19 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=10 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
n=4 Participants
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above Lower Limit of Quantification (AUC0-t) of Pimasertib: Single Dose
|
54.0 hour*nanogram/milliliter
Geometric Coefficient of Variation 57.2
|
125.4 hour*nanogram/milliliter
Geometric Coefficient of Variation 42.4
|
230.9 hour*nanogram/milliliter
Geometric Coefficient of Variation 60.9
|
456.2 hour*nanogram/milliliter
Geometric Coefficient of Variation 25.5
|
581.8 hour*nanogram/milliliter
Geometric Coefficient of Variation 45.4
|
735.2 hour*nanogram/milliliter
Geometric Coefficient of Variation 47.2
|
863.8 hour*nanogram/milliliter
Geometric Coefficient of Variation 52.8
|
905.0 hour*nanogram/milliliter
Geometric Coefficient of Variation 92.8
|
1268.2 hour*nanogram/milliliter
Geometric Coefficient of Variation 31.9
|
SECONDARY outcome
Timeframe: Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3).Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. '"n" =Subjects evaluable for this outcome measure for specified categories for each reporting group, respectively.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=11 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=10 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=8 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=9 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=13 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=2 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=16 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=5 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
n=1 Participants
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above Lower Limit of Quantification (AUC0-t) of Pimasertib: Multiple Dose
|
131.4 hour*nanogram/milliliter
Geometric Coefficient of Variation 45.5
|
307.2 hour*nanogram/milliliter
Geometric Coefficient of Variation 75.4
|
321.9 hour*nanogram/milliliter
Geometric Coefficient of Variation 29.9
|
679.4 hour*nanogram/milliliter
Geometric Coefficient of Variation 53.7
|
761.2 hour*nanogram/milliliter
Geometric Coefficient of Variation 35.5
|
628.0 hour*nanogram/milliliter
Geometric Coefficient of Variation 28.2
|
991.6 hour*nanogram/milliliter
Geometric Coefficient of Variation 66.1
|
2195.2 hour*nanogram/milliliter
Geometric Coefficient of Variation 97.3
|
2144.7 hour*nanogram/milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not available as only 1 subject was evaluated for this group.
|
SECONDARY outcome
Timeframe: Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. 'N'(number of subjects analyzed)=subjects evaluable for this measure.
The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. It is obtained from AUC0-t plus AUCt-infinity.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=4 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=6 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=7 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=8 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=4 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=18 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=5 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
n=3 Participants
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pimasertib: Single Dose
|
80.5 hour*nanogram/milliliter
Geometric Coefficient of Variation 52.9
|
145.2 hour*nanogram/milliliter
Geometric Coefficient of Variation 42.1
|
315.6 hour*nanogram/milliliter
Geometric Coefficient of Variation 76.3
|
562.1 hour*nanogram/milliliter
Geometric Coefficient of Variation 33.3
|
734.9 hour*nanogram/milliliter
Geometric Coefficient of Variation 49.7
|
858.4 hour*nanogram/milliliter
Geometric Coefficient of Variation 49.6
|
1027.4 hour*nanogram/milliliter
Geometric Coefficient of Variation 49.2
|
1530.7 hour*nanogram/milliliter
Geometric Coefficient of Variation 135.3
|
1873.9 hour*nanogram/milliliter
Geometric Coefficient of Variation 68.8
|
SECONDARY outcome
Timeframe: Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.
The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. It is obtained from AUC0-t plus AUCt-infinity.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=7 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=6 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=6 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=11 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=2 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=11 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=2 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
n=1 Participants
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pimasertib: Multiple Dose
|
226.2 hour*nanogram/milliliter
Geometric Coefficient of Variation 91.0
|
789.3 hour*nanogram/milliliter
Geometric Coefficient of Variation 1038.0
|
451.2 hour*nanogram/milliliter
Geometric Coefficient of Variation 39.4
|
1030.2 hour*nanogram/milliliter
Geometric Coefficient of Variation 51.6
|
938.0 hour*nanogram/milliliter
Geometric Coefficient of Variation 46.6
|
786.7 hour*nanogram/milliliter
Geometric Coefficient of Variation 21.2
|
1270.8 hour*nanogram/milliliter
Geometric Coefficient of Variation 104.3
|
2712.6 hour*nanogram/milliliter
Geometric Coefficient of Variation 456.7
|
2830.7 hour*nanogram/milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not available as only 1 subject was evaluated for this group.
|
SECONDARY outcome
Timeframe: Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. 'N'(number of subjects analyzed)=subjects evaluable for this measure.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed. Data for Pimasertib 75 mg arm was not available for all the regimens combined, thus reported as separate outcome measure and not included in this outcome.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=4 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=6 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=7 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=8 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=4 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=18 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=3 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Oral Clearance (CL/f) of Pimasertib: Single Dose
|
99.43 liter/hour
Geometric Coefficient of Variation 52.86
|
103.29 liter/hour
Geometric Coefficient of Variation 42.07
|
72.88 liter/hour
Geometric Coefficient of Variation 76.28
|
53.37 liter/hour
Geometric Coefficient of Variation 33.26
|
57.15 liter/hour
Geometric Coefficient of Variation 49.72
|
52.42 liter/hour
Geometric Coefficient of Variation 49.59
|
58.40 liter/hour
Geometric Coefficient of Variation 49.21
|
48.03 liter/hour
Geometric Coefficient of Variation 68.78
|
—
|
SECONDARY outcome
Timeframe: Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. 'N'(number of subjects analyzed)=subjects evaluable for this measure and "n" = subjects evaluable for the specified regimen.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=4 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Oral Clearance (CL/f) of Pimasertib for Pimasertib 75 mg Reporting Arm: Single Dose
Regimen 1 (n=0)
|
NA liter/hour
Standard Deviation NA
For Regimen 1, number of subjects analyzed = 0 as no subject received 75 mg dose.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Apparent Oral Clearance (CL/f) of Pimasertib for Pimasertib 75 mg Reporting Arm: Single Dose
Regimen 2 (n=3)
|
93 liter/hour
Standard Deviation 103.367
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Apparent Oral Clearance (CL/f) of Pimasertib for Pimasertib 75 mg Reporting Arm: Single Dose
Regimen 3 (n=1)
|
45 liter/hour
Standard Deviation NA
Standard Deviation could not be estimated as there was only 1 participant assessed for the specified category.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. 'N'(number of subjects analyzed)=subjects evaluable for this measure.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=11 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=8 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=7 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=12 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=2 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=13 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=4 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
n=1 Participants
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Oral Clearance (CL/f) of Pimasertib: Multiple Dose
|
60.90 liter/hour
Geometric Coefficient of Variation 45.51
|
46.74 liter/hour
Geometric Coefficient of Variation 78.85
|
66.52 liter/hour
Geometric Coefficient of Variation 33.40
|
37.95 liter/hour
Geometric Coefficient of Variation 47.59
|
55.80 liter/hour
Geometric Coefficient of Variation 35.90
|
69.23 liter/hour
Geometric Coefficient of Variation 33.40
|
65.11 liter/hour
Geometric Coefficient of Variation 65.69
|
34.44 liter/hour
Geometric Coefficient of Variation 119.51
|
41.96 liter/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not available as only 1 subject was evaluated for this group.
|
SECONDARY outcome
Timeframe: Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. 'N'(number of subjects analyzed)=subjects evaluable for this measure.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Data for Pimasertib 75 mg arm was not available for all the regimens combined, thus reported as separate outcome measure and not included in this outcome.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=4 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=6 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=7 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=8 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=4 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=18 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=3 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib:Single Dose
|
757.5 liter
Geometric Coefficient of Variation 48.3
|
524.8 liter
Geometric Coefficient of Variation 51.5
|
320.8 liter
Geometric Coefficient of Variation 60.1
|
308.8 liter
Geometric Coefficient of Variation 27.1
|
320.2 liter
Geometric Coefficient of Variation 40.4
|
260.8 liter
Geometric Coefficient of Variation 46.9
|
250.3 liter
Geometric Coefficient of Variation 48.5
|
235.2 liter
Geometric Coefficient of Variation 24.2
|
—
|
SECONDARY outcome
Timeframe: Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. 'N'(number of subjects analyzed)=subjects evaluable for this measure and "n" = subjects evaluable for the specified regimen.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=4 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib for Pimasertib 75 mg Reporting Arm:Single Dose
Regimen 1 (n = 0)
|
NA liter
Standard Deviation NA
For Regimen 1, number of subjects analyzed = 0 as no subject received 75 mg dose.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib for Pimasertib 75 mg Reporting Arm:Single Dose
Regimen 2 (n = 3)
|
442.2 liter
Standard Deviation 214.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib for Pimasertib 75 mg Reporting Arm:Single Dose
Regimen 3 (n = 1)
|
196.0 liter
Standard Deviation NA
Standard Deviation could not be estimated as there was only 1 participant assessed for the specified category.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)Population: Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. 'N'(number of subjects analyzed)=subjects evaluable for this measure.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=9 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=7 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=6 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
n=6 Participants
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
n=11 Participants
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
n=2 Participants
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
n=11 Participants
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
n=2 Participants
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
n=1 Participants
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib: Multiple Dose
|
601.7 liter
Geometric Coefficient of Variation 79.2
|
863.7 liter
Geometric Coefficient of Variation 193.5
|
332.8 liter
Geometric Coefficient of Variation 14.5
|
207.8 liter
Geometric Coefficient of Variation 46.8
|
293.1 liter
Geometric Coefficient of Variation 27.6
|
395.1 liter
Geometric Coefficient of Variation 52.9
|
422.0 liter
Geometric Coefficient of Variation 79.2
|
689.9 liter
Geometric Coefficient of Variation 16.0
|
305.2 liter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not available as only 1 subject was evaluated for this group.
|
SECONDARY outcome
Timeframe: Day 29 of every alternate 29-day cycle until progression reported between day of first subject randomized, September 2009, until cut-off date, December 2012Population: The efficacy analysis set included all subjects who received at least 1 administration of planned dose of pimasertib and had at least 1 efficacy assessment after the first dose. 'N' (number of subjects analyzed)=subjects evaluable for this outcome measure.
The best overall response was reported as either of the following: (1) Morphologic complete remission (CR) = normalization of the peripheral blood absolute neutrophil count (PBANC) \>1.0x10\^9 per liter (/L), platelets \>100x10\^9 /L, bone marrow aspirate with less than or equal to (\<=) 5 percent (%) blasts, no blasts with Auer rods (AML only). (2) Complete remission with incomplete blood count recovery (CRi) = Same as CR without normalization of PBANC and platelet count. (3) Partial remission (PR) = normalization of PBANC \>1.0x10\^9/L, platelets \>100x10\^9/L, and at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts less than (\<) 5%. (4) Progressive disease (PD) = \>50% increase in peripheral blood or bone marrow blasts. (5) Stable disease (SD) = Subjects who failed to achieve CR, CRi or PR and without criteria for PD.
Outcome measures
| Measure |
Regimen 1 (Part 1)
n=20 Participants
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=22 Participants
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=7 Participants
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 30 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 42 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 45 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 60 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 75 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Pimasertib 90 mg (All Regimens [Part 1])
Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Subjects With Best Overall Response
CR
|
0.0 Percentage of Subjects
|
0.0 Percentage of Subjects
|
0.0 Percentage of Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Best Overall Response
CRi
|
0.0 Percentage of Subjects
|
0.0 Percentage of Subjects
|
0.0 Percentage of Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Best Overall Response
PR
|
0.0 Percentage of Subjects
|
0.0 Percentage of Subjects
|
0.0 Percentage of Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Best Overall Response
SD
|
60.0 Percentage of Subjects
|
77.3 Percentage of Subjects
|
71.4 Percentage of Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Best Overall Response
PD
|
40.0 Percentage of Subjects
|
22.7 Percentage of Subjects
|
28.6 Percentage of Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: This outcome measure was not analyzed as the trial was terminated during safety run-in (Part 1).
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
Outcome measures
Outcome data not reported
Adverse Events
Regimen 1 (Part 1)
Serious events: 24 serious events
Other events: 32 other events
Deaths: 0 deaths
Regimen 2 (Part 1)
Serious events: 28 serious events
Other events: 30 other events
Deaths: 0 deaths
Regimen 3 (Part 1)
Serious events: 12 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen 1 (Part 1)
n=33 participants at risk
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=32 participants at risk
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=15 participants at risk
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
12.1%
4/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
28.1%
9/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Cardiac disorders
Acute coronary syndrome
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Cardiac disorders
Atrial fibrillation
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Photopsia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Visual impairment
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Caecitis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Stomatitis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Asthenia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Disease progression
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Face oedema
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Fatigue
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
General physical health deterioration
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Oedema peripheral
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Pyrexia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
15.6%
5/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Bacteraemia
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Cellulitis
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
9.4%
3/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Clostridial infection
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Clostridium difficile colitis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Device related infection
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Enterocolitis infectious
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Human herpes virus 6 infection
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Infection
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Influenza
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Lung Infection
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Pneumonia
|
21.2%
7/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
12.5%
4/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
20.0%
3/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Pneumonia fungal
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Sepsis
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
9.4%
3/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Septic shock
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Tonsillitis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Injury, poisoning and procedural complications
Overdose
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Asparatate aminotransferase increased
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Depressed level of consciousness
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Subdural hygroma
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Renal and urinary disorders
Nephritic syndrome
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Renal and urinary disorders
Renal failure acute
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
3/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Vascular disorders
Deep vein thrombosis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Vascular disorders
Hypotension
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Vascular disorders
Varicose vein
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Syncope
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
Other adverse events
| Measure |
Regimen 1 (Part 1)
n=33 participants at risk
Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 2 (Part 1)
n=32 participants at risk
Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
Regimen 3 (Part 1)
n=15 participants at risk
Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
|
|---|---|---|---|
|
Eye disorders
Erythema of eyelid
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
3/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Cardiac disorders
Atrial fibrillation
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Cardiac disorders
Atrioventricular block second degree
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Cardiac disorders
Bradycardia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Cardiac disorders
Pericardial effusion
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Cardiac disorders
Pneumopericardium
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Cardiac disorders
Sinus tachycardia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Cardiac disorders
Tachycardia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Blepharitis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
9.4%
3/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Conjunctival hyperaemia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Dry eye
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Macular Degeneration
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Macular oedema
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Metamorphopsia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Ocular hypertension
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Optic disc haemorrhage
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Periorbital oedema
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Photopsia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Retinal detachment
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
12.5%
4/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Retinal oedema
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Retinal vein occlusion
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Scotoma
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Vision blurred
|
12.1%
4/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
15.6%
5/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Visual impairment
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Eye disorders
Xerophthalmia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.1%
4/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
3/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
9.4%
3/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.4%
14/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
50.0%
16/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
53.3%
8/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Dry mouth
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Dysphagia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Faecal incontinence
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Gingival bleeding
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Gingival inflammation
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
12.1%
4/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Nausea
|
30.3%
10/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
21.9%
7/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Oral disorder
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Proctalgia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Stomatitis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Stomatitis necrotising
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
6/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
18.8%
6/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Asthenia
|
12.1%
4/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
15.6%
5/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Chest pain
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Chills
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Face oedema
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Fatigue
|
15.2%
5/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
15.6%
5/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Generalised oedema
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Hyperthermia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Influenza like illness
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Localised oedema
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Malaise
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Oedema
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Oedema peripheral
|
18.2%
6/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
25.0%
8/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
26.7%
4/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Pyrexia
|
21.2%
7/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
25.0%
8/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Immune system disorders
Graft versus host disease in intestine
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Immune system disorders
Graft versus host disease in skin
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Anal abscess
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Bacteraemia
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Cellulitis
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Herpes simplex ophthalmic
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Human herpesvirus 6 virus infection
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Localised infection
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Oral candidiasis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Paronychia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Rhinitis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Sepsis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Sinusitis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Staphylococcal sepsis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
9.1%
3/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Alanine aminotransferase increased
|
18.2%
6/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
12.5%
4/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Aspartate aminotransferase increased
|
24.2%
8/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
21.9%
7/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
20.0%
3/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood albumin decreased
|
12.1%
4/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood alkaline phosphatase increased
|
15.2%
5/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
9.4%
3/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood bilirubin increased
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood calcium decreased
|
12.1%
4/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood creatine increased
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood creatinine
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood glucose increased
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood magnesium decreased
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood potassium decreased
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood sodium decreased
|
12.1%
4/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood urea increased
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Blood uric acid increased
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Electrocardiogram QT prolonged
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Gamma-glutamyltransferase
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.1%
3/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Haemoglobin decreased
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
International normalised ratio increased
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Neutrophil count decreased
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Weight decreased
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Investigations
Weight increased
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
9.4%
3/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
3/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
9.4%
3/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
20.0%
3/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
20.0%
3/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
26.7%
4/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
3/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
15.6%
5/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
9.4%
3/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.1%
4/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Dizziness
|
21.2%
7/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
15.6%
5/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Dysgeusia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Headache
|
9.1%
3/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
18.8%
6/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Somnolence
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Nervous system disorders
Syncope
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Psychiatric disorders
Agitation
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Psychiatric disorders
Anxiety
|
9.1%
3/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Psychiatric disorders
Confusional state
|
9.1%
3/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
9.4%
3/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Psychiatric disorders
Hallucination
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Psychiatric disorders
Insomnia
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Renal and urinary disorders
Dysuria
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Renal and urinary disorders
Haematuria
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Renal and urinary disorders
Proteinuria
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Renal and urinary disorders
Renal failure acute
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Reproductive system and breast disorders
Testis discomfort
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
5/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
9.4%
3/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.2%
5/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
15.6%
5/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
13.3%
2/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.1%
2/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.1%
4/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
18.8%
6/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
26.7%
4/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Vascular disorders
Flushing
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Vascular disorders
Hot flush
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Vascular disorders
Hypertension
|
3.0%
1/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.2%
2/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Vascular disorders
Hypotension
|
12.1%
4/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
18.8%
6/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
6.7%
1/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
General disorders
Infusion site oedema
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/33 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
3.1%
1/32 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
0.00%
0/15 • Up to 3 years
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. SAEs and Other AEs (non-SAEs) were reported.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER