NCT01362790 · ADVERSE EVENTS

Adverse events

SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma · Source last updated 2019-06-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Date treatment consent signed to date off study, approximately 64 months and 26 days.
Other-event reporting threshold: 0%

No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Mesothelioma Pilot Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	6 / 11	11 / 11	5 / 11
Mesothelioma Pilot Phase Regimen B Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	8 / 8	8 / 8	8 / 8
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	3 / 7	7 / 7	3 / 7
Phase 2 Pleural Mesothelioma Pilot Expansion Phase Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	9 / 15	15 / 15	9 / 15
Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.	1 / 8	8 / 8	1 / 8
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	1 / 4	4 / 4	1 / 4
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	0 / 0	0 / 0	0 / 0

Group identifiers: EG000: Mesothelioma Pilot Phase Regimen A · EG001: Mesothelioma Pilot Phase Regimen B · EG002: Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase · EG003: Phase 2 Pleural Mesothelioma Pilot Expansion Phase · EG004: Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A · EG005: Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A · EG006: Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
15
num Events
1
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
11
num Events
5
group Id
EG001
num Affected
5
num At Risk
8
num Events
5
group Id
EG002
num Affected
2
num At Risk
7
num Events
2
group Id
EG003
num Affected
4
num At Risk
15
num Events
4
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
1
num At Risk
4
num Events
1
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
15
num Events
1
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Death
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
3
num At Risk
8
num Events
3
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
group Id
EG003
num Affected
4
num At Risk
15
num Events
4
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
1
num At Risk
8
num Events
2
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
15
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
group Id
EG003
num Affected
0
num At Risk
15
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
15
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Death
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
15
num Events
1
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Respiratory failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
group Id
EG001
num Affected
5
num At Risk
8
num Events
10
group Id
EG002
num Affected
1
num At Risk
7
num Events
2
group Id
EG003
num Affected
7
num At Risk
15
num Events
10
group Id
EG004
num Affected
3
num At Risk
8
num Events
6
group Id
EG005
num Affected
2
num At Risk
4
num Events
5
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
4
group Id
EG003
num Affected
0
num At Risk
15
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
15
num Events
1
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
2
num At Risk
8
num Events
4
group Id
EG002
num Affected
2
num At Risk
7
num Events
6
group Id
EG003
num Affected
2
num At Risk
15
num Events
2
group Id
EG004
num Affected
2
num At Risk
8
num Events
4
group Id
EG005
num Affected
1
num At Risk
4
num Events
1
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
15
num Events
1
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
11
num Events
17
group Id
EG001
num Affected
4
num At Risk
8
num Events
15
group Id
EG002
num Affected
2
num At Risk
7
num Events
2
group Id
EG003
num Affected
7
num At Risk
15
num Events
19
group Id
EG004
num Affected
5
num At Risk
8
num Events
10
group Id
EG005
num Affected
4
num At Risk
4
num Events
7
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
4
group Id
EG001
num Affected
3
num At Risk
8
num Events
13
group Id
EG002
num Affected
3
num At Risk
7
num Events
10
group Id
EG003
num Affected
3
num At Risk
15
num Events
5
group Id
EG004
num Affected
3
num At Risk
8
num Events
11
group Id
EG005
num Affected
2
num At Risk
4
num Events
5
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
15
num Events
1
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
2
num At Risk
8
num Events
2
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
15
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
15
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Anal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
8
num At Risk
11
num Events
31
group Id
EG001
num Affected
7
num At Risk
8
num Events
44
group Id
EG002
num Affected
4
num At Risk
7
num Events
28
group Id
EG003
num Affected
11
num At Risk
15
num Events
39
group Id
EG004
num Affected
8
num At Risk
8
num Events
35
group Id
EG005
num Affected
4
num At Risk
4
num Events
12
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
11
num Events
7
group Id
EG001
num Affected
3
num At Risk
8
num Events
3
group Id
EG002
num Affected
3
num At Risk
7
num Events
5
group Id
EG003
num Affected
3
num At Risk
15
num Events
3
group Id
EG004
num Affected
2
num At Risk
8
num Events
4
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Anorexia

Complete source fields

description

No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

event Groups

deaths Num Affected
5
deaths Num At Risk
11
description
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
id
EG000
other Num Affected
11
other Num At Risk
11
serious Num Affected
6
serious Num At Risk
11
title
Mesothelioma Pilot Phase Regimen A
deaths Num Affected
8
deaths Num At Risk
8
description
Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.
id
EG001
other Num Affected
8
other Num At Risk
8
serious Num Affected
8
serious Num At Risk
8
title
Mesothelioma Pilot Phase Regimen B
deaths Num Affected
3
deaths Num At Risk
7
description
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
id
EG002
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
deaths Num Affected
9
deaths Num At Risk
15
description
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
id
EG003
other Num Affected
15
other Num At Risk
15
serious Num Affected
9
serious Num At Risk
15
title
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
deaths Num Affected
1
deaths Num At Risk
8
description
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.
id
EG004
other Num Affected
8
other Num At Risk
8
serious Num Affected
1
serious Num At Risk
8
title
Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A
deaths Num Affected
1
deaths Num At Risk
4
description
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
id
EG005
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
deaths Num Affected
0
deaths Num At Risk
0
description
Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
id
EG006
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
group Id
EG001
num Affected
5
num At Risk
8
num Events
10
group Id
EG002
num Affected
1
num At Risk
7
num Events
2
group Id
EG003
num Affected
7
num At Risk
15
num Events
10
group Id
EG004
num Affected
3
num At Risk
8
num Events
6
group Id
EG005
num Affected
2
num At Risk
4
num Events
5
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
4
group Id
EG003
num Affected
0
num At Risk
15
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
15
num Events
1
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
2
num At Risk
8
num Events
4
group Id
EG002
num Affected
2
num At Risk
7
num Events
6
group Id
EG003
num Affected
2
num At Risk
15
num Events
2
group Id
EG004
num Affected
2
num At Risk
8
num Events
4
group Id
EG005
num Affected
1
num At Risk
4
num Events
1
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
15
num Events
1
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
11
num Events
17
group Id
EG001
num Affected
4
num At Risk
8
num Events
15
group Id
EG002
num Affected
2
num At Risk
7
num Events
2
group Id
EG003
num Affected
7
num At Risk
15
num Events
19
group Id
EG004
num Affected
5
num At Risk
8
num Events
10
group Id
EG005
num Affected
4
num At Risk
4
num Events
7
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
4
group Id
EG001
num Affected
3
num At Risk
8
num Events
13
group Id
EG002
num Affected
3
num At Risk
7
num Events
10
group Id
EG003
num Affected
3
num At Risk
15
num Events
5
group Id
EG004
num Affected
3
num At Risk
8
num Events
11
group Id
EG005
num Affected
2
num At Risk
4
num Events
5
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
15
num Events
1
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
2
num At Risk
8
num Events
2
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
15
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
15
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Anal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
8
num At Risk
11
num Events
31
group Id
EG001
num Affected
7
num At Risk
8
num Events
44
group Id
EG002
num Affected
4
num At Risk
7
num Events
28
group Id
EG003
num Affected
11
num At Risk
15
num Events
39
group Id
EG004
num Affected
8
num At Risk
8
num Events
35
group Id
EG005
num Affected
4
num At Risk
4
num Events
12
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
11
num Events
7
group Id
EG001
num Affected
3
num At Risk
8
num Events
3
group Id
EG002
num Affected
3
num At Risk
7
num Events
5
group Id
EG003
num Affected
3
num At Risk
15
num Events
3
group Id
EG004
num Affected
2
num At Risk
8
num Events
4
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Anorexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
15
num Events
1
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
11
num Events
5
group Id
EG001
num Affected
5
num At Risk
8
num Events
5
group Id
EG002
num Affected
2
num At Risk
7
num Events
2
group Id
EG003
num Affected
4
num At Risk
15
num Events
4
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
1
num At Risk
4
num Events
1
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
15
num Events
1
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Death
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
3
num At Risk
8
num Events
3
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
group Id
EG003
num Affected
4
num At Risk
15
num Events
4
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
1
num At Risk
8
num Events
2
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
15
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
group Id
EG003
num Affected
0
num At Risk
15
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
15
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Death
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
15
num Events
1
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
4
num Events
0
group Id
EG006
num Affected
0
num At Risk
0
num Events
0
term
Respiratory failure

time Frame

Date treatment consent signed to date off study, approximately 64 months and 26 days.

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Preserved source evidence · Not medical advice