Trial Outcomes & Findings for Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors (NCT NCT03333915)
NCT ID: NCT03333915
Last Updated: 2025-02-04
Results Overview
A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation or was worsening in severity from baseline (pretreatment).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
128 participants
Primary outcome timeframe
From first dose to within 30 days of last dose of pamiparib (approximately 36 months)
Results posted on
2025-02-04
Participant Flow
This study consisted of 2 Phases. Phase 1 (December 2016 to December 2019) in which 15 participants were enrolled and Phase 2 (December 2017 to August 2021) in which 113 participants were enrolled. Primary data cut off date for Phase 1 was 24 December 2019 and Primary cut-off date for Phase 2 was 24 August 2020.
Participant milestones
| Measure |
Phase 1: 20 Milligram (mg) Pamiparib
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 2: 60 mg Pamiparib in Platinum-sensitive Ovarian Cancer (PSOC)
Participants with PSOC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 2: 60 mg Pamiparib in Platinum-resistant Ovarian Cancer (PROC)
Participants with PROC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
7
|
90
|
23
|
|
Overall Study
COMPLETED
|
4
|
3
|
6
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
90
|
23
|
Reasons for withdrawal
| Measure |
Phase 1: 20 Milligram (mg) Pamiparib
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 2: 60 mg Pamiparib in Platinum-sensitive Ovarian Cancer (PSOC)
Participants with PSOC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 2: 60 mg Pamiparib in Platinum-resistant Ovarian Cancer (PROC)
Participants with PROC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Disease Progression
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
37
|
18
|
|
Overall Study
Sponsor's Decision
|
0
|
0
|
0
|
48
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
5
|
1
|
Baseline Characteristics
Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=7 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 2: 60 mg Pamiparib in PSOC
n=90 Participants
Participants with PSOC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 2: 60 mg Pamiparib in PROC
n=23 Participants
Participants with PROC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 6.55 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 13.95 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 7.94 • n=4 Participants
|
52.9 years
STANDARD_DEVIATION 7.97 • n=21 Participants
|
53.87 years
STANDARD_DEVIATION 8.14 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
128 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
128 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
128 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)Population: Safety Analysis Set includes all participants who received at least one dose of pamiparib
A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation or was worsening in severity from baseline (pretreatment).
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=7 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 1: Number of Participants With Treatment- Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Participants with at least 1 TEAE
|
4 Number of participants
|
4 Number of participants
|
7 Number of participants
|
|
Phase 1: Number of Participants With Treatment- Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Treatment-Emergent SAEs
|
0 Number of participants
|
1 Number of participants
|
2 Number of participants
|
PRIMARY outcome
Timeframe: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)Population: Safety Analysis Set
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=7 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examinations and Electrocardiograms (ECGs)
ECGs
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examinations and Electrocardiograms (ECGs)
Physical Findings
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
PRIMARY outcome
Timeframe: Up to approximately 2 years and 8 monthsPopulation: Efficacy Evaluable Set defined as all participants in the Safety Analysis Set who had measurable disease at baseline per RECIST v1.1. participants with available data were included in the analysis.
ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=82 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=19 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR) in High Grade Ovarian Cancer (HGOC) Both PSOC and PROC as Assessed by Independent Radiology Review Committee (IRC)
|
68.3 Percentage of participants
Interval 57.1 to 78.1
|
31.6 Percentage of participants
Interval 12.6 to 56.6
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dosePopulation: PK Analysis Set was defined as all participants for whom valid PK parameters could be estimated.
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=7 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase I: Maximum Observed Plasma Concentration (Cmax)
Day 1
|
718.4 ng/mL
Geometric Coefficient of Variation 18.9
|
1633.7 ng/mL
Geometric Coefficient of Variation 12.2
|
2302.5 ng/mL
Geometric Coefficient of Variation 30.1
|
|
Phase I: Maximum Observed Plasma Concentration (Cmax)
Day 10
|
1280.1 ng/mL
Geometric Coefficient of Variation 70.5
|
5213.8 ng/mL
Geometric Coefficient of Variation 25.6
|
5861.3 ng/mL
Geometric Coefficient of Variation 29.2
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dosePopulation: PK Analysis Set
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=7 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase I: Time to Reach Cmax (Tmax)
Day 1
|
1.01 hours
Interval 0.52 to 3.78
|
0.98 hours
Interval 0.97 to 1.05
|
1.13 hours
Interval 1.0 to 6.08
|
|
Phase I: Time to Reach Cmax (Tmax)
Day 10
|
1.04 hours
Interval 0.92 to 2.12
|
1.10 hours
Interval 0.98 to 1.95
|
1.13 hours
Interval 0.98 to 1.97
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dosePopulation: PK Analysis Set
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=7 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase I: Terminal Elimination Half-life (t1/2)
|
12.14 hours
Interval 8.15 to 18.15
|
11.79 hours
Interval 8.74 to 20.14
|
13.77 hours
Interval 6.54 to 34.91
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dosePopulation: PK Analysis Set
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=7 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase I: Apparent Clearance (CL/F)
|
1.95 Liters/hour (L/h)
Geometric Coefficient of Variation 43.85
|
2.07 Liters/hour (L/h)
Geometric Coefficient of Variation 61.09
|
2.19 Liters/hour (L/h)
Geometric Coefficient of Variation 79.41
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dosePopulation: Pharmacokinetic (PK) Analysis Set includes all participants for whom valid pamiparib PK parameters could be estimated.
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=7 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf)
|
1020.5 Hours*nanograms/milliliter (h*ng/mL)
Geometric Coefficient of Variation 43.9
|
1912.7 Hours*nanograms/milliliter (h*ng/mL)
Geometric Coefficient of Variation 61.1
|
27454.4 Hours*nanograms/milliliter (h*ng/mL)
Geometric Coefficient of Variation 79.4
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dosePopulation: PK Analysis Set
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=7 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase I: Apparent Volume of Distribution During Terminal Phase (Vz/F)
|
34.2 Liters
Geometric Coefficient of Variation 23.6
|
35.2 Liters
Geometric Coefficient of Variation 21.8
|
37.2 Liters
Geometric Coefficient of Variation 33.2
|
SECONDARY outcome
Timeframe: Up to approximately 36 monthsPopulation: Efficacy Evaluable Set includes all participants in the safety analysis set who had the measurable disease at baseline per RECIST v1.1 and had at least one post-baseline tumor assessment unless discontinued due to clinical progression or death prior to assessment
ORR is defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR)
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=5 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase I: Confirmed Objective Response Rate (ORR) as Assessed by the Investigator Per RECIST v1.1
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
0 Percentage of participants
Interval 0.0 to 52.2
|
SECONDARY outcome
Timeframe: Up to approximately 36 monthsPopulation: Efficacy Evaluable Set includes all participants in the safety analysis set who had the measurable disease at baseline per RECIST v1.1 and had at least one post-baseline tumor assessment unless discontinued due to clinical progression or death prior to assessment
DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD)
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=5 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 1: Disease Control Rate (DCR) Assessed by the Investigator Per RECIST v1.1
|
50.0 Percentage of participants
Interval 6.3 to 93.2
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
80.0 Percentage of participants
Interval 28.4 to 99.5
|
SECONDARY outcome
Timeframe: Up to approximately 36 monthsPopulation: Efficacy Evaluable Set
CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=5 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase I: Clinical Benefit Rate (CBR) Assessed by the Investigator Per RECIST v1.1
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
40.0 Percentage of participants
Interval 5.3 to 85.3
|
SECONDARY outcome
Timeframe: Up to approximately 36 monthsPopulation: Efficacy Evaluable Set; Only the number of responders were included in the analysis.
DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=1 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=1 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 1: Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1
|
30.4 months
NA = Not estimable due to insufficient number of events
|
NA months
NA = Not estimable due to insufficient number of events
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 36 monthsPopulation: Safety Analysis Set
PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=4 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=7 Participants
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase I : Progression Free Survival (PFS)
|
2.2 Months
Interval 1.48 to 34.53
|
NA Months
Interval 1.45 to
NA = Not estimable due to insufficient number of events
|
5.6 Months
Interval 1.48 to
NA = Not estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 8 monthsPopulation: Efficacy Analysis Set; Participants with available data were included in the analysis
ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=82 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=19 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR) by Investigator Per RECIST v1.1
|
64.6 Percentage of participants
Interval 53.3 to 74.9
|
26.3 Percentage of participants
Interval 9.1 to 51.2
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 8 monthsPopulation: Efficacy Analysis Set; Participants with available data were included in the analysis
DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD)
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=90 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=23 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Disease Control Rate by Investigator Per RECIST v1.1
|
96.3 Percentage of participants
Interval 89.7 to 99.2
|
78.9 Percentage of participants
Interval 54.4 to 93.9
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 8 monthsPopulation: Efficacy Analysis Set; Participants with available data were included in the analysis
CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=90 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=23 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Clinical Benefit Rate by Investigator Per RECIST v1.1
|
73.2 Percentage of participants
Interval 62.2 to 82.4
|
52.6 Percentage of participants
Interval 28.0 to 75.6
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 8 monthsPopulation: CA-125 Evaluable Analysis Set is defined as a subset of participants in the Safety Analysis with baseline CA-125 \>/= 2 X upper limit of normal (ULN)
CA-125 response is defined the percentage of participants with at least 50% reduction in CA-125 levels from pre-treatment sample
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=90 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=23 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Carcinoma Antigen-125 (C(A-125) Response Rate by Gynecologic Cancer Inter Group (GCIG )Criteria
|
79.7 Percentage of participants
Interval 68.8 to 88.2
|
38.1 Percentage of participants
Interval 18.1 to 61.8
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 8 monthsPopulation: Efficacy Evaluable Set : Participants with available data were included in the analysis
DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=82 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=19 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Duration of Response as Assessed by Investigator Per RECIST v1.1
|
11.1 Months
Interval 9.0 to 14.52
|
6.9 Months
Interval 4.93 to 19.78
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 8 monthsPopulation: Safety Analysis Set
PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=90 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=23 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Progression Free Survival as Assessed by the Investigator Per RECIST v1.1
|
10.4 Months
Interval 8.31 to 15.15
|
5.5 Months
Interval 2.27 to 6.24
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 8 monthsPopulation: Safety Analysis Set
OS is defined as time from the first dose of study medication to the date of death due to any cause
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=90 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=23 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Overall Survival (OS) as Assessed by Investigator
|
34.1 Months
Interval 29.08 to
NA = Not estimable due to insufficient number of events
|
13.6 Months
Interval 7.13 to 19.75
|
—
|
SECONDARY outcome
Timeframe: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)Population: Safety Analysis Set
A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation or was worsening in severity from baseline (pretreatment). All clinically significant abnormalities in physical examinations, laboratory tests and ECGs are reported as adverse events (AE) in the AE section.
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=90 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=23 Participants
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Number of Participants With Treatment- Emergent Adverse Events and Serious Adverse Events
Participants With At Least one TEAE
|
90 Number of participants
|
23 Number of participants
|
—
|
|
Phase 2: Number of Participants With Treatment- Emergent Adverse Events and Serious Adverse Events
Treatment Emergent SAEs
|
36 Number of participants
|
15 Number of participants
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dosePopulation: PK Analysis Set: Participants with at least one available PK parameter at the specified visit were included in the analysis. Phase 2 PK analyses were performed for all Phase 2 participants combined per protocol.
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=15 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC0-12)
Cycle 1 Day 1
|
16841.5 hours*nanograms/milliliter (h*ng/mL)
Geometric Coefficient of Variation 20.5
|
—
|
—
|
|
Phase 2: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC0-12)
Cycle 2 Day 1
|
48802.4 hours*nanograms/milliliter (h*ng/mL)
Geometric Coefficient of Variation 24.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dosePopulation: PK Analysis Set: Participants with at least one available PK parameter at the specified visit were included in the analysis. Phase 2 PK analyses were performed for all Phase 2 participants combined per protocol.
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=15 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Maximum Observed Plasma Concentration (Cmax)
Cycle 1Day 1
|
2275.1 ng/mL
Geometric Coefficient of Variation 19.6
|
—
|
—
|
|
Phase 2: Maximum Observed Plasma Concentration (Cmax)
Cycle 2 Day 1
|
5251.5 ng/mL
Geometric Coefficient of Variation 22.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dosePopulation: PK Analysis Set: Participants with at least one available PK parameter at the specified visit were included in the analysis. Phase 2 PK analyses were performed for all Phase 2 participants combined per protocol.
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=15 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Time to Reach Cmax (Tmax)
Cycle 1 Day 1
|
1.88 hours
Interval 0.95 to 3.98
|
—
|
—
|
|
Phase 2: Time to Reach Cmax (Tmax)
Cycle 2 Day 1
|
1.98 hours
Interval 0.5 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dosePopulation: PK Analysis Set: Participants with at least one available PK parameter at the specified visit were included in the analysis. Phase 2 PK analyses were performed for all Phase 2 participants combined per protocol..
Outcome measures
| Measure |
Phase 1: 20 mg Pamiparib
n=15 Participants
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|
|
Phase 2: Area Under the Plasma Concentration-time Curve From 0 to the 9 Hours Post-dose (AUC0-9)
Cycle 2 Day 1
|
38259.3 h*ng/mL
Geometric Coefficient of Variation 23.5
|
—
|
—
|
|
Phase 2: Area Under the Plasma Concentration-time Curve From 0 to the 9 Hours Post-dose (AUC0-9)
Cycle 1 Day 1
|
13577.2 h*ng/mL
Geometric Coefficient of Variation 20.3
|
—
|
—
|
Adverse Events
Phase 1: 20 mg Pamiparib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1: 40 mg Pamiparib
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1: 60 mg Pamiparib
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 2: 60 mg Pamiparib in Platinum-sensitive Ovarian Cancer (PSOC)
Serious events: 36 serious events
Other events: 90 other events
Deaths: 37 deaths
Phase 2: 60 mg Pamiparib in Platinum-resistant Ovarian Cancer (PROC)
Serious events: 15 serious events
Other events: 22 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Phase 1: 20 mg Pamiparib
n=4 participants at risk
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 participants at risk
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=7 participants at risk
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 2: 60 mg Pamiparib in Platinum-sensitive Ovarian Cancer (PSOC)
n=90 participants at risk
Participants with PSOC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 2: 60 mg Pamiparib in Platinum-resistant Ovarian Cancer (PROC)
n=23 participants at risk
Participants with PROC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
17.8%
16/90 • Number of events 22 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
30.4%
7/23 • Number of events 11 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.7%
2/23 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
2.2%
2/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.7%
2/23 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
2.2%
2/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
General disorders
Death
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Immune system disorders
Food allergy
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
2.2%
2/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.4%
4/90 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
Other adverse events
| Measure |
Phase 1: 20 mg Pamiparib
n=4 participants at risk
Participants received a single dose of 20 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 20 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 40 mg Pamiparib
n=4 participants at risk
Participants received a single dose of 40 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 40 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 1: 60 mg Pamiparib
n=7 participants at risk
Participants received a single dose of 60 mg pamiparib orally on Day 1 followed by a one day treatment free period (Day 2), and 60 mg pamiparib twice a day for the following 21 days (Day 3 to Day 23) until unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 2: 60 mg Pamiparib in Platinum-sensitive Ovarian Cancer (PSOC)
n=90 participants at risk
Participants with PSOC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
Phase 2: 60 mg Pamiparib in Platinum-resistant Ovarian Cancer (PROC)
n=23 participants at risk
Participants with PROC received 60 mg pamiparib twice a day on Day 1 of Cycle 1 (21-day cycle) and continuously in all subsequent cycles until occurrence of unacceptable toxicities, disease progression, withdrawal of consent, investigator discretion, or delay of treatment due to unresolved toxicities for more than 21 days
|
|---|---|---|---|---|---|
|
General disorders
General physical health deterioration
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.4%
4/90 • Number of events 9 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.6%
2/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
90.0%
81/90 • Number of events 204 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
91.3%
21/23 • Number of events 43 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Blood and lymphatic system disorders
Erythropenia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
2.2%
2/90 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
22.2%
20/90 • Number of events 71 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
13.0%
3/23 • Number of events 13 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
6.7%
6/90 • Number of events 16 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.4%
13/90 • Number of events 27 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.7%
2/23 • Number of events 15 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.9%
8/90 • Number of events 13 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
50.0%
2/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
71.4%
5/7 • Number of events 9 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Cardiac disorders
Ventricular arrhythmia
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Cardiac disorders
Ventricular extrasystoles
|
25.0%
1/4 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
2.2%
2/90 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.6%
2/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
16.7%
15/90 • Number of events 25 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.7%
2/23 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
11.1%
10/90 • Number of events 17 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.7%
2/23 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.6%
2/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.6%
2/7 • Number of events 6 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.9%
8/90 • Number of events 11 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 10 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Ascites
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
7.8%
7/90 • Number of events 10 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
21.7%
5/23 • Number of events 6 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
42.9%
3/7 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
22.2%
20/90 • Number of events 40 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
26.1%
6/23 • Number of events 7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
2.2%
2/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.7%
2/23 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
4/4 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
75.0%
3/4 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
71.4%
5/7 • Number of events 11 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
67.8%
61/90 • Number of events 173 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
69.6%
16/23 • Number of events 34 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
50.0%
2/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.6%
2/7 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
51.1%
46/90 • Number of events 123 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
47.8%
11/23 • Number of events 47 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
General disorders
Asthenia
|
75.0%
3/4 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
100.0%
4/4 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
71.4%
5/7 • Number of events 10 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.9%
26/90 • Number of events 36 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
26.1%
6/23 • Number of events 9 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 6 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
2.2%
2/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
General disorders
Malaise
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
16.7%
15/90 • Number of events 30 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.7%
2/23 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.7%
2/23 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
General disorders
Pain
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
General disorders
Peripheral swelling
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.6%
2/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
11.1%
10/90 • Number of events 11 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.4%
4/90 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.6%
2/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
18.9%
17/90 • Number of events 32 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
17.4%
4/23 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
6.7%
6/90 • Number of events 14 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
24.4%
22/90 • Number of events 38 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
21.7%
5/23 • Number of events 7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
26.7%
24/90 • Number of events 36 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
17.4%
4/23 • Number of events 6 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Bilirubin conjugated increased
|
25.0%
1/4 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.6%
2/7 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
5.6%
5/90 • Number of events 13 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
13.0%
3/23 • Number of events 6 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Bilirubin urine present
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
6.7%
6/90 • Number of events 8 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.7%
2/23 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
15.6%
14/90 • Number of events 46 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
17.4%
4/23 • Number of events 6 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Blood bilirubin unconjugated increased
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.4%
4/90 • Number of events 15 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
10.0%
9/90 • Number of events 10 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
6.7%
6/90 • Number of events 11 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.7%
2/23 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Blood pressure increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Blood triglycerides increased
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.4%
4/90 • Number of events 7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 8 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Electrocardiogram QT prolonged
|
50.0%
2/4 • Number of events 6 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.6%
2/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Gamma-glutamyltransferase increased
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.6%
2/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
17.8%
16/90 • Number of events 22 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
26.1%
6/23 • Number of events 6 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
71.4%
5/7 • Number of events 9 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
21.1%
19/90 • Number of events 49 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
21.7%
5/23 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
75.0%
3/4 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
57.1%
4/7 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
63.3%
57/90 • Number of events 262 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
56.5%
13/23 • Number of events 57 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
2.2%
2/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Neutrophil percentage increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
42.9%
3/7 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
31.1%
28/90 • Number of events 78 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
43.5%
10/23 • Number of events 21 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Procalcitonin increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Protein urine present
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.6%
2/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
2.2%
2/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Total bile acids increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Urine ketone body present
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
Weight decreased
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
12.2%
11/90 • Number of events 13 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
17.4%
4/23 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
White blood cell count decreased
|
50.0%
2/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
75.0%
3/4 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
71.4%
5/7 • Number of events 8 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
61.1%
55/90 • Number of events 245 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
60.9%
14/23 • Number of events 41 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.4%
4/90 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
5.6%
5/90 • Number of events 7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
75.0%
3/4 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
75.0%
3/4 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
42.9%
3/7 • Number of events 9 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
33.3%
30/90 • Number of events 44 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
21.7%
5/23 • Number of events 7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
50.0%
2/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.9%
8/90 • Number of events 8 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.4%
4/90 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.7%
2/23 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
50.0%
2/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
50.0%
2/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
8.9%
8/90 • Number of events 10 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
75.0%
3/4 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.4%
4/90 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
6.7%
6/90 • Number of events 6 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.4%
4/90 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 5 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
28.6%
2/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.4%
13/90 • Number of events 25 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
6.7%
6/90 • Number of events 7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.4%
4/90 • Number of events 10 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
7.8%
7/90 • Number of events 8 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
6.7%
6/90 • Number of events 9 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
2.2%
2/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
2.2%
2/90 • Number of events 2 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/90 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/7 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 3 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
3.3%
3/90 • Number of events 4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/23 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
0.00%
0/4 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
14.3%
1/7 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
1.1%
1/90 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
4.3%
1/23 • Number of events 1 • Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Adverse Events were coded based on MedDRA version 22.0 for Phase 1, and version 24.0 for Phase 2. All clinically significant abnormalities in physical examinations, laboratory tests and ECGs in Phase 1 and Phase 2 are reported as adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights
- Publication restrictions are in place
Restriction type: OTHER