Trial Outcomes & Findings for A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML). (NCT NCT00946647)
NCT ID: NCT00946647
Last Updated: 2020-08-04
Results Overview
Dose limiting toxicity (DLT) was defined as a toxicity requiring treatment withdrawal and included the following: Non-hematologic toxicity qualifying for DLT and Hematologic toxicity qualifying for DLT
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
113 participants
Primary outcome timeframe
within the first 28 days (cycle 1)
Results posted on
2020-08-04
Participant Flow
In phase l a total of 31 patients were treated with escalating dose of PAN, 20 mg 30 mg \& 40 mg. In phase ll a total of 82 patients were actually randomized with 40 patients assigned to PAN+5-Aza and 42 patients assigned to 5-Aza.
For phase I, approximately 26 patients were planned to be enrolled in cohorts of at least three MTD evaluable patients per dose level. For phase ll, approximately 80 patients were planned to be enrolled, 40 patients per arm.
Participant milestones
| Measure |
PAN + 5-Aza 20 mg
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle
|
Panobinostat + 5-Azacytidine
In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15.
In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.
|
5-Azacytidine
The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis.
Dose of 5-Azacytidine : 75 mg/m\^2 subcutaneously daily from Day 1 to Day 7.
|
|---|---|---|---|---|---|
|
Phase 1 Part
STARTED
|
6
|
18
|
7
|
0
|
0
|
|
Phase 1 Part
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Part
NOT COMPLETED
|
6
|
18
|
7
|
0
|
0
|
|
Phase ll Part
STARTED
|
0
|
0
|
0
|
40
|
42
|
|
Phase ll Part
Safety Set
|
0
|
0
|
0
|
38
|
42
|
|
Phase ll Part
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase ll Part
NOT COMPLETED
|
0
|
0
|
0
|
40
|
42
|
Reasons for withdrawal
| Measure |
PAN + 5-Aza 20 mg
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle
|
Panobinostat + 5-Azacytidine
In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15.
In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.
|
5-Azacytidine
The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis.
Dose of 5-Azacytidine : 75 mg/m\^2 subcutaneously daily from Day 1 to Day 7.
|
|---|---|---|---|---|---|
|
Phase 1 Part
Adverse Event
|
2
|
5
|
3
|
0
|
0
|
|
Phase 1 Part
Disease progression
|
3
|
6
|
1
|
0
|
0
|
|
Phase 1 Part
Withdrawal by Subject
|
1
|
4
|
3
|
0
|
0
|
|
Phase 1 Part
Abnormal values
|
0
|
2
|
0
|
0
|
0
|
|
Phase 1 Part
Reason missing
|
0
|
1
|
0
|
0
|
0
|
|
Phase ll Part
Untreated
|
0
|
0
|
0
|
0
|
2
|
|
Phase ll Part
Adverse Event
|
0
|
0
|
0
|
10
|
6
|
|
Phase ll Part
Withdrawal by Subject
|
0
|
0
|
0
|
8
|
6
|
|
Phase ll Part
Administrative problems
|
0
|
0
|
0
|
3
|
8
|
|
Phase ll Part
Death
|
0
|
0
|
0
|
7
|
4
|
|
Phase ll Part
Disease progression
|
0
|
0
|
0
|
6
|
14
|
|
Phase ll Part
Protocol Violation
|
0
|
0
|
0
|
4
|
2
|
|
Phase ll Part
Subj cond no longer required study drug
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML).
Baseline characteristics by cohort
| Measure |
PAN + 5-Aza 20 mg
n=6 Participants
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
n=18 Participants
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
n=7 Participants
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
Panobinostat + 5-Azacytidine
n=40 Participants
In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15.
In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.
|
5-Azacytidine
n=42 Participants
The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis.
Dose of 5-Azacytidine : 75 mg/m\^2 subcutaneously daily from Day 1 to Day 7.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
< 65
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
14 participants
n=4 Participants
|
8 participants
n=21 Participants
|
29 participants
n=8 Participants
|
|
Age, Customized
>= 65
|
5 participants
n=5 Participants
|
13 participants
n=7 Participants
|
6 participants
n=5 Participants
|
26 participants
n=4 Participants
|
34 participants
n=21 Participants
|
84 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
69 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 participants
n=5 Participants
|
15 participants
n=7 Participants
|
6 participants
n=5 Participants
|
29 participants
n=4 Participants
|
36 participants
n=21 Participants
|
91 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
7 participants
n=4 Participants
|
2 participants
n=21 Participants
|
9 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
11 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: within the first 28 days (cycle 1)Population: Maximum Tolerated Dose (MTD) determining set: Consisted of all patients of the safety set who either received sufficient study treatment as defined in the minimum exposure criteria in Cycle 1 (patients had to have 100% of the planned dose of each compound), and had sufficient safety evaluations or discontinued due to DLT in Cycle 1.
Dose limiting toxicity (DLT) was defined as a toxicity requiring treatment withdrawal and included the following: Non-hematologic toxicity qualifying for DLT and Hematologic toxicity qualifying for DLT
Outcome measures
| Measure |
PAN + 5-Aza 20 mg
n=5 Participants
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
n=14 Participants
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
n=7 Participants
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT) (Phase lb)
|
1 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: within the first 28 days (cycle 1)Population: Maximum Tolerated Dose (MTD) determining set: Consisted of all patients of the safety set who either received sufficient study treatment as defined in the minimum exposure criteria in Cycle 1 (patients had to have 100% of the planned dose of each compound), and had sufficient safety evaluations or discontinued due to DLT in Cycle 1.
Dose limiting toxicity (DLT) was defined as a toxicity requiring treatment withdrawal and included the following: Non-hematologic toxicity qualifying for DLT and Hematologic toxicity qualifying for DLT
Outcome measures
| Measure |
PAN + 5-Aza 20 mg
n=5 Participants
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
n=14 Participants
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
n=7 Participants
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
|---|---|---|---|
|
Number of Dose Limiting Toxicity (DLT) (Phase lb)
|
2 DLTs
|
6 DLTs
|
4 DLTs
|
PRIMARY outcome
Timeframe: 48 monthsPopulation: Full analysis set: Consisted of all patients who were randomized to one of the two treatment arms
Composite complete response is defined as complete response (CR), Complete response with incomplete blood count recovery (CRi) or bone marrow complete response (BM-CR) as defined by the International Working Group (IWG) response criteria.
Outcome measures
| Measure |
PAN + 5-Aza 20 mg
n=40 Participants
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
n=42 Participants
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
|---|---|---|---|
|
Composite Complete Response (Phase Llb)
|
27.5 Percentage of participants
Interval 14.6 to 43.89
|
14.3 Percentage of participants
Interval 5.43 to 28.54
|
—
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: Full analysis set: Consisted of all patients who were randomized to one of the two treatment arms
This is the best overall response as measured by Clinical response. Clinical response is defined as having complete remission (CR), bone marrow complete remission (BM-CR), partial remission or hematologic improvement (HI) as defined by the International Working Group (IWG) response criteria.
Outcome measures
| Measure |
PAN + 5-Aza 20 mg
n=31 Participants
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
n=29 Participants
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
|---|---|---|---|
|
Clinical Response Other Than Composite Clinical Response for Myeloid Dysplastic Syndromes(MDS)/Chronic Myelomonocytic Leukemia (CMML) Patients Per Investigator (Phase Llb)
|
41.9 Percentage of participants
Interval 24.5 to 60.9
|
41.4 Percentage of participants
Interval 23.5 to 61.1
|
—
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: Full analysis set: Consisted of all patients who were randomized to one of the two treatment arms
This is the best overall response as measured by Clinical response. Clinical response is defined as having complete remission (CR), complete remission with incomplete blood count recovery (CRi) or partial remission as defined by the International Working Group (IWG) response criteria.
Outcome measures
| Measure |
PAN + 5-Aza 20 mg
n=9 Participants
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
n=13 Participants
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
|---|---|---|---|
|
Clinical Response Other Than Composite Clinical Response for Acute Myelogenous Leukemia (AML) Patients Per Investigator (Phase Llb)
|
22.2 Percentage of participants
Interval 2.8 to 60.0
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
—
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: Full analysis set (FAS): Consisted of all patients who were randomized to one of the two treatment arms.
Best overall response as measured by complete remission (CR) or bone marrow CR (BM-CR) or partial remission (PR) or hematologic improvement (HI). Overall response patients achieved other than the composite CR by individual response category: CR, CRi, mCR or PR as defined by the International Working Group (IWG) response criteria.
Outcome measures
| Measure |
PAN + 5-Aza 20 mg
n=31 Participants
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
n=29 Participants
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
|---|---|---|---|
|
Overall Response Rate (ORR) Assessed by Best Overall Response: Participants With MDS/CMML Per Investigator (Phase Llb)
Partial remission (PR)
|
0.0 Percentage of participants
|
6.9 Percentage of participants
|
—
|
|
Overall Response Rate (ORR) Assessed by Best Overall Response: Participants With MDS/CMML Per Investigator (Phase Llb)
Clinical response (CR, BM-CR, PR, HI)
|
41.9 Percentage of participants
|
41.4 Percentage of participants
|
—
|
|
Overall Response Rate (ORR) Assessed by Best Overall Response: Participants With MDS/CMML Per Investigator (Phase Llb)
Complete remission (CR)
|
16.1 Percentage of participants
|
6.9 Percentage of participants
|
—
|
|
Overall Response Rate (ORR) Assessed by Best Overall Response: Participants With MDS/CMML Per Investigator (Phase Llb)
Bone marrow CR (BM-CR)
|
12.9 Percentage of participants
|
3.4 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: Full analysis set (FAS): Consisted of all patients who were randomized to one of the two treatment arms.
Best overall response as measured by complete remission (CR) or complete response with incomplete blood count recovery (CRi) or partial remission (PR). Overall response patients achieved other than the composite CR by individual response category: CR, CRi or PR.
Outcome measures
| Measure |
PAN + 5-Aza 20 mg
n=9 Participants
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
n=13 Participants
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
|---|---|---|---|
|
Overall Response Rate (ORR) Assessed by Best Overall Response: Participants With AML Per Investigator (Phase Llb)
Clinical response (CR, CRi, PR)
|
22.2 Percentage of participants
|
30.8 Percentage of participants
|
—
|
|
Overall Response Rate (ORR) Assessed by Best Overall Response: Participants With AML Per Investigator (Phase Llb)
Complete remission (CR)
|
11.1 Percentage of participants
|
15.4 Percentage of participants
|
—
|
|
Overall Response Rate (ORR) Assessed by Best Overall Response: Participants With AML Per Investigator (Phase Llb)
Compl remiss. with incompl blood cnt recovery(CRi)
|
11.1 Percentage of participants
|
7.7 Percentage of participants
|
—
|
|
Overall Response Rate (ORR) Assessed by Best Overall Response: Participants With AML Per Investigator (Phase Llb)
Partial remission (PR)
|
0.0 Percentage of participants
|
7.7 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: Full analysis set: Consisted of all patients who were randomized to one of the two treatment arms
Hematologic response consists of Erythroid response (HI-E), Platelet response (HI-P) and Neutrophil response (HI-N). HI-E: Hgb increase by ≥ 1.5 g/dL over pretreatment \& relevant reduction of units of RBC transfusions by an absolute number of at least 4 units of PRBCs/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation. HI-P: Absolute increase of ≥ 30 x 109/L over pretreatment or patients starting with ≥ 20 x 109/L platelets OR increase from \<20 x 109/L at pretreatment to \> 20 x 109/L and by at least 100%. HI-N: At least 100% increase and an absolute increase \> 0.5 x 109/L over pretreatment value.
Outcome measures
| Measure |
PAN + 5-Aza 20 mg
n=31 Participants
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
n=29 Participants
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
|---|---|---|---|
|
Hematologic Improvement (HI) for Myeloid Dysplastic Syndromes(MDS)/Chronic Myelomonocytic Leukemia (CMML) Patients Per Investigator (Phase Llb)
Neutrophil response (HI-N)
|
19.4 Percentage of participants
Interval 7.5 to 37.5
|
13.8 Percentage of participants
Interval 3.9 to 31.7
|
—
|
|
Hematologic Improvement (HI) for Myeloid Dysplastic Syndromes(MDS)/Chronic Myelomonocytic Leukemia (CMML) Patients Per Investigator (Phase Llb)
Erythroid response (HI-E)
|
25.8 Percentage of participants
Interval 11.9 to 44.6
|
31.0 Percentage of participants
Interval 15.3 to 50.8
|
—
|
|
Hematologic Improvement (HI) for Myeloid Dysplastic Syndromes(MDS)/Chronic Myelomonocytic Leukemia (CMML) Patients Per Investigator (Phase Llb)
Platelet response (HI-P)
|
35.5 Percentage of participants
Interval 19.2 to 54.6
|
24.1 Percentage of participants
Interval 10.3 to 43.5
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full analysis set: Consisted of all patients who were randomized to one of the two treatment arms
Overall survival was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact. Patients not known to have died were censored for 'Lost to follow-up' if the time between their last contact date and the analysis cut-off date was longer than 3 months and 2 weeks (104 days) during the first year after study evaluation completion, and longer than 6 months and 2 weeks (194 days), thereafter. The 1-year survival rate was obtained from the Kaplan-Meier analysis of overall survival, and its variance was estimated by Greenwood's formula.
Outcome measures
| Measure |
PAN + 5-Aza 20 mg
n=40 Participants
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
n=42 Participants
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
|---|---|---|---|
|
1-year Survival Rate (Phase Llb)
|
14.9 months
Interval 10.4 to
NA - The follow-up was too short that the quantiles of the survival distribution could not be estimated.
|
15.6 months
Interval 11.4 to
NA - The follow-up was too short that the quantiles of the survival distribution could not be estimated.
|
—
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: Full analysis set: Consisted of all patients who were randomized to one of the two treatment arms
Time to progression (TTP) was defined as the time from the date of randomization to the date of the first documented PD per investigator's assessment or death due to study indication. Time to progression was analyzed by the Kaplan Meier method. Based on the Guidelines for Implementation of international working group (IWG) response criteria in AML, MDS and CMML according to Cheson 2003 and 2006.
Outcome measures
| Measure |
PAN + 5-Aza 20 mg
n=40 Participants
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 30 mg
n=42 Participants
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
PAN + 5-Aza 40 mg
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle.
|
|---|---|---|---|
|
Time to Progression (TTP) (Phase Llb)
|
NA months
Interval 11.1 to
NA - The follow-up was too short that the quantiles of the survival distribution could not be estimated.
|
15.2 months
Interval 11.0 to
NA - The follow-up was too short that the quantiles of the survival distribution could not be estimated.
|
—
|
Adverse Events
Phase Ib PAN + 5-Aza 20mg
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase Ib PAN + 5-Aza 30mg
Serious events: 15 serious events
Other events: 18 other events
Deaths: 1 deaths
Phase Ib PAN + 5-Aza 40mg
Serious events: 6 serious events
Other events: 7 other events
Deaths: 2 deaths
Phase IIb PAN + 5-Aza
Serious events: 28 serious events
Other events: 38 other events
Deaths: 6 deaths
Phase IIb 5-Aza
Serious events: 28 serious events
Other events: 38 other events
Deaths: 3 deaths
Phase Ib and IIb
Serious events: 82 serious events
Other events: 107 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Phase Ib PAN + 5-Aza 20mg
n=6 participants at risk
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 g/m2/day for 7 days in Week 1 of each cycle
|
Phase Ib PAN + 5-Aza 30mg
n=18 participants at risk
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle
|
Phase Ib PAN + 5-Aza 40mg
n=7 participants at risk
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle
|
Phase IIb PAN + 5-Aza
n=38 participants at risk
In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15.
In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.
|
Phase IIb 5-Aza
n=42 participants at risk
The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis.
Dose of 5-Azacytidine: 75 mg/m\^2 subcutaneously daily from Day 1 to Day
|
Phase Ib and IIb
n=111 participants at risk
Patients in the Panobinostat + 5-Azacytidine arm and in the 5-Azacytidine arm
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
33.3%
6/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
26.3%
10/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
6/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
24.3%
27/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
6.3%
7/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Eye disorders
Diplopia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Eye disorders
Uveitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Gastroenteritis eosinophilic
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Death
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Tongue haematoma
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Asthenia
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Fatigue
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Erysipelas
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Impetigo
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Oral bacterial infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Parotitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
21.1%
8/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.5%
4/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.4%
16/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
10.5%
4/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.5%
4/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
8.1%
9/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Septic shock
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Heart rate increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Troponin T increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign anorectal neoplasm
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell lung cancer metastatic
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Embolism venous
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
Other adverse events
| Measure |
Phase Ib PAN + 5-Aza 20mg
n=6 participants at risk
In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 g/m2/day for 7 days in Week 1 of each cycle
|
Phase Ib PAN + 5-Aza 30mg
n=18 participants at risk
In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle
|
Phase Ib PAN + 5-Aza 40mg
n=7 participants at risk
In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle
|
Phase IIb PAN + 5-Aza
n=38 participants at risk
In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15.
In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.
|
Phase IIb 5-Aza
n=42 participants at risk
The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis.
Dose of 5-Azacytidine: 75 mg/m\^2 subcutaneously daily from Day 1 to Day
|
Phase Ib and IIb
n=111 participants at risk
Patients in the Panobinostat + 5-Azacytidine arm and in the 5-Azacytidine arm
|
|---|---|---|---|---|---|---|
|
Eye disorders
Blepharitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Eye disorders
Cataract
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Eye disorders
Diplopia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Eye disorders
Eye irritation
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Eye disorders
Optic atrophy
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Eye disorders
Pupillary reflex impaired
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Eye disorders
Visual impairment
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
3/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
33.3%
6/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
15.8%
6/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.2%
18/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
22.2%
4/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.0%
10/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Abdominal wall mass
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Anal incontinence
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Anal skin tags
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Angina bullosa haemorrhagica
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
61.1%
11/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
26.3%
10/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
38.1%
16/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
37.8%
42/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
4/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
83.3%
15/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
57.1%
4/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
57.9%
22/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
21.4%
9/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
48.6%
54/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
44.4%
8/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
57.1%
4/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
31.6%
12/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
33.3%
14/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
36.0%
40/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
15.8%
6/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.9%
11/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
22.2%
4/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
10.5%
4/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.9%
11/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
44.4%
8/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.1%
16/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
23.8%
10/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
35.1%
39/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
3/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
66.7%
12/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
57.1%
4/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
47.4%
18/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
23.8%
10/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.3%
47/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Angina pectoris
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Arrhythmia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.2%
8/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Bundle branch block left
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Extrasystoles
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Ear and labyrinth disorders
Hypoacusis
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Gastroenteritis eosinophilic
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Gingival bleeding
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Haemorrhoids
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
13.2%
5/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.9%
11/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
77.8%
14/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
100.0%
7/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
60.5%
23/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
18/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
59.5%
66/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Proctalgia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.5%
4/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Swollen tongue
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Tongue coated
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.2%
8/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Vomiting
|
83.3%
5/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
50.0%
9/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
57.1%
4/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.1%
16/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
12/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
41.4%
46/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Asthenia
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
33.3%
6/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
26.3%
10/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
6/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
22.5%
25/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Catheter site discharge
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Catheter site erythema
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Catheter site haematoma
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Catheter site phlebitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Chest pain
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Chills
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
22.2%
4/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
10.8%
12/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Extravasation
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Facial pain
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Fatigue
|
66.7%
4/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
66.7%
12/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
85.7%
6/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
26.3%
10/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
38.1%
16/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
43.2%
48/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Feeling cold
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Feeling hot
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Generalised oedema
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Injection site bruising
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
27.8%
5/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.9%
11/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Injection site haematoma
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Injection site irritation
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Injection site pain
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
27.8%
5/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.9%
11/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Injection site rash
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.2%
8/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Localised oedema
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Malaise
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.5%
4/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Mass
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Mucosal inflammation
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Non-cardiac chest pain
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
10.5%
4/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.9%
11/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Oedema peripheral
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
22.2%
4/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
57.1%
4/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
21.1%
8/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
21.4%
9/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
24.3%
27/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Pain
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Puncture site erythema
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
44.4%
8/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
57.1%
4/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
47.4%
18/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
21.4%
9/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
36.9%
41/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Swelling
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
General disorders
Thirst
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Immune system disorders
Allergic oedema
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Immune system disorders
Allergy to chemicals
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Anal abscess
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Anal fungal infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Anal infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Bacterial infection
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Candida infection
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Carbuncle
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.5%
4/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
6.3%
7/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Clostridium difficile colitis
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Clostridium difficile infection
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Fungal infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Haemorrhoid infection
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Human polyomavirus infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Localised infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Mucormycosis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Oral herpes
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
6.3%
7/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Puncture site infection
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Staphylococcal infection
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
6.3%
7/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.5%
4/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.0%
10/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
8.1%
9/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Tongue injury
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Dyschezia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Poor venous access
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Shock
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.2%
8/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
10.5%
4/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.2%
8/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood albumin decreased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
27.8%
5/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
57.1%
4/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
10.5%
4/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
12.6%
14/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood folate decreased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood potassium increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Blood urine present
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
C-reactive protein increased
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.2%
8/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Coagulation test abnormal
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Glucose urine present
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Left ventricular end-diastolic pressure increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
15.8%
6/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.9%
11/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Nitrite urine present
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
21.1%
8/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.9%
11/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Protein urine present
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Prothrombin time shortened
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Troponin I increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Troponin T increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Urine output decreased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Vitamin D decreased
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
18.4%
7/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
6/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.4%
16/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
10.5%
4/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Investigations
White blood cells urine positive
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
33.3%
6/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
71.4%
5/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
23.7%
9/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
6/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
26.1%
29/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.0%
10/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
6.3%
7/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
6.3%
7/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
27.8%
5/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.0%
10/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
50.0%
3/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
38.9%
7/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.4%
16/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
55.6%
10/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
18.4%
7/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
6/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
24.3%
27/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.0%
10/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
6.3%
7/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
10.5%
4/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
8.1%
9/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
27.8%
5/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.5%
4/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
12.6%
14/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
13.2%
5/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.5%
4/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
12.6%
14/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.0%
10/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
22.2%
4/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
10.5%
4/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.7%
13/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
22.2%
4/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
13.2%
5/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
13.5%
15/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
22.2%
4/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
10.8%
12/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
22.2%
4/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
57.1%
4/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
18.4%
7/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
7/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
21.6%
24/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Hypotonia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Sciatica
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Psychiatric disorders
Disorientation
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Psychiatric disorders
Fear
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
13.2%
5/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
13.5%
15/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Psychiatric disorders
Personality change
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Psychiatric disorders
Sleep disorder
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Bladder pain
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Reproductive system and breast disorders
Scrotal erythema
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Reproductive system and breast disorders
Scrotal oedema
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Reproductive system and breast disorders
Scrotal pain
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
33.3%
6/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
18.4%
7/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
6/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
20.7%
23/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
3/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
33.3%
6/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.5%
4/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.2%
18/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
22.2%
4/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
13.2%
5/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
6/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
17.1%
19/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal blistering
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
50.0%
3/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.9%
5/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
12.6%
14/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
6.3%
7/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.4%
6/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.5%
4/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.0%
10/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Koebner phenomenon
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
3.6%
4/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Papule
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
38.9%
7/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.9%
3/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.7%
13/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
10.5%
4/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
7.1%
3/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
8.1%
9/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
22.2%
4/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
15.8%
6/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.5%
4/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.4%
16/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
28.6%
2/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.7%
3/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
10.5%
4/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.6%
1/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
1.8%
2/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
16.7%
3/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.9%
5/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.9%
11/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
22.2%
4/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
2.4%
1/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.5%
5/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Hypotension
|
33.3%
2/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
11.1%
2/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
42.9%
3/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.3%
2/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
4.8%
2/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
9.9%
11/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Lymphoedema
|
16.7%
1/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Pallor
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
14.3%
1/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/6 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
5.6%
1/18 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/7 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/38 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.00%
0/42 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
0.90%
1/111 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER