Trial Outcomes & Findings for Phase I, Dosage-finding and PK Study of IV Topotecan and Erlotinib With Refractory Solid Tumors (NCT NCT00611468)
NCT ID: NCT00611468
Last Updated: 2011-08-22
Results Overview
The MTD of topotecan was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
MTD was assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21).
Results posted on
2011-08-22
Participant Flow
The study was open to enrollment at one community oncology clinic from June 2006 to November 2008.
Informed consent was obtained from all subjects. All subjects underwent a screening period that could last up to 4 weeks during which pre-study assessments were completed. All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment.
Participant milestones
| Measure |
Dosage Level 1 for MTD Determination
Dosage level 1 was topotecan 0.75 mg/m2 and erlotinib 150 mg.
|
Dosage Level 2 for MTD Determination
Dosage level 2 was topotecan 1.0 mg/m2 and erlotinib 150 mg.
|
Dosage Level 3 for MTD Determination
Dosage level 3 was topotecan 1.25 mg/m2 and erlotinib 150 mg.
|
PK Group for Additional PK Data
Additional patients were enrolled for enhanced PK parameter estimation
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
6
|
13
|
|
Overall Study
COMPLETED
|
3
|
6
|
6
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I, Dosage-finding and PK Study of IV Topotecan and Erlotinib With Refractory Solid Tumors
Baseline characteristics by cohort
| Measure |
Treatment Group: Intravenous Topotecan and Oral Erlotinib
n=29 Participants
All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age Continuous
|
58.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: MTD was assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21).Population: DLT information was available for 3 patients who received a topotecan dose of 0.75 mg/M\^2, for 6 patients who received a topotecan dose of 1.0 mg/M\^2, and for 6 patients who recived a topotecan dose of 1.25 mg/M\^2. 1 additional patient received a dose 1.0 mg/M\^2 but withdrew before completing cycle 1. This patient had no DLT and was replaced.
The MTD of topotecan was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.
Outcome measures
| Measure |
Treatment Group: Intravenous Topotecan and Oral Erlotinib
n=15 Participants
All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
|
|---|---|
|
Maximum Tolerated Dosage (MTD) of Intravenous Topotecan When Given in Combination With Oral Erlotinib
|
1.0 mg/m^2
|
PRIMARY outcome
Timeframe: DLT were assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21)Population: DLT were assessed using NCI CTCAE version 3.0. After MTD was determined, 13 additional patients were enrolled to enhance estimation of PK parameters. The first 8 were enrolled at dose 2. Because 4 of these patients experienced a DLT, the remaining 5 patients were enrolled at dose level 1. Of these, 1 experienced a DLT.
Outcome measures
| Measure |
Treatment Group: Intravenous Topotecan and Oral Erlotinib
n=28 Participants
All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
|
|---|---|
|
Dosage Limiting Toxicities
Dose Level 1 (N = 8)
|
1 Participants
|
|
Dosage Limiting Toxicities
Dose Level 2 (N = 14)
|
5 Participants
|
|
Dosage Limiting Toxicities
Dose Level 3 (N = 6)
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 Week 1 and Day 1 Week 3Population: Of the 29 consenting patients, 18 provided information that could be used in the analysis. 1 patient withdrew, 2 had samples that were inevaluable due to lab error, and 8 went off study before receiving topotecan with erlotinib.
Outcome measures
| Measure |
Treatment Group: Intravenous Topotecan and Oral Erlotinib
n=18 Participants
All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
|
|---|---|
|
Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Mean Clearance)
Without Erlotinib
|
9.41 L/h/m^2
Standard Deviation 3.40
|
|
Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Mean Clearance)
With Erlotinib
|
8.60 L/h/m^2
Standard Deviation 3.04
|
PRIMARY outcome
Timeframe: Day 1 Week 1 and Day 1 Week 3Population: Of the 29 consenting patients, 18 provided information that could be used in the analysis. However, only 13 were able to be analyzed for the renal clearance because in 5 patients the amount of topotecan measured in the urine was more than the topotecan dose that was given. Renal clearance was not calculated for those patients.
Outcome measures
| Measure |
Treatment Group: Intravenous Topotecan and Oral Erlotinib
n=13 Participants
All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
|
|---|---|
|
Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Renal Clearance)
Without Erlotinib
|
4.95 L/h/m^2
Standard Deviation 2.38
|
|
Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Renal Clearance)
With Erlotinib
|
4.07 L/h/m^2
Standard Deviation 1.87
|
PRIMARY outcome
Timeframe: Day 1 Week 1 and Day 1 Week 3Population: Of the 29 consenting patients, 18 provided information that could be used in the analysis. 1 patient withdrew, 2 had samples that were inevaluable due to lab error, and 8 went off study before receiving topotecan with erlotinib.
Outcome measures
| Measure |
Treatment Group: Intravenous Topotecan and Oral Erlotinib
n=18 Participants
All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
|
|---|---|
|
Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Dose-Normalized AUC)
Without Erlotinib
|
91.8 ng*h/mL
Standard Deviation 24.1
|
|
Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Dose-Normalized AUC)
With Erlotinib
|
99.1 ng*h/mL
Standard Deviation 42.2
|
SECONDARY outcome
Timeframe: BaselinePopulation: Pharmacokinetic studies were done for all 29 consenting patients (one of whom later withdrew).
Each subgroup lists the gene on which a polymorphism occurred (e.g., CYP3A4), the name of the polymorphism (e.g., \*1), whether it was heterozygous or a variant, the number of subjects with available data, and the number who had the polymorphism.
Outcome measures
| Measure |
Treatment Group: Intravenous Topotecan and Oral Erlotinib
n=29 Participants
All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
|
|---|---|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
CYP3A4 / *1 / Wild-type, N = (28)
|
20 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
CYP3A4 / *1 / Heterozygous, N = (28)
|
0 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
CYP3A5 / *6 / Heterozygous, N = (29)
|
2 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
CYP3A5 / *6 / Variant, N = (29)
|
0 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
CYP3A4 / *1 / Variant, N = (28)
|
8 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
CYP3A5 / *3 / Wild-type, N = (28)
|
19 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
CYP3A5 / *3 / Heterozygous, N = (28)
|
3 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
CYP3A5 / *3 / Variant, N = (28)
|
6 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
CYP3A5 / *6 / Wild-type, N = (29)
|
27 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
UGT1A1 / *28 / Wild-type N = (29)
|
15 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
UGT1A1 / *28 / Heterozygous, N = (29)
|
14 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
UGT1A1 / *28 / Variant, N = (29)
|
0 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
BCRP / 34G > A / Wild-type, N = (29)
|
26 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
BCRP / 34G > A / Heterozygous, N = (29)
|
3 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
BCRP / 34G > A / Variant, N = (29)
|
0 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
BCRP / 421C > A / Wild-type, N = (29)
|
25 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
BCRP / 421C > A / Heterozygous, N = (29)
|
4 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
BCRP / 421C > A / Variant, N = (29)
|
0 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
P-gp / 2677G > T / Wild-type N = (29)
|
13 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
P-gp / 2677G > T / Heterozygous, N = (29)
|
12 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
P-gp / 2677G > T / Variant, N = (29)
|
4 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
P-gp / 3435C> T / Wild-type, N = (29)
|
13 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
P-gp / 3435C> T / Heterozygous, N = (29)
|
7 Participants
|
|
Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
P-gp / 3435C> T / Variant, N = (29)
|
9 Participants
|
SECONDARY outcome
Timeframe: Every 6 weeks until the end of study treatmentPopulation: After the determination of MTD, an additional 13 patients were enrolled to enhance estimation of PK parameters. The first 8 patients were enrolled at dose level 2, 4 of whom experienced a DLT. Thus, the remaining 5 patients were enrolled at dose 1. One of these patients experienced a DLT.
Outcome measures
| Measure |
Treatment Group: Intravenous Topotecan and Oral Erlotinib
n=28 Participants
All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
|
|---|---|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 2 ( N = 14) Not Evaluable (NE)
|
4 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 3 ( N = 6) Complete Response (CR)
|
0 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 1 (N = 8) Complete Response (CR)
|
0 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 1 (N = 8) Partial Response (PR)
|
0 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 1 (N = 8) Stable Disease (SD)
|
3 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 1 (N = 8) Progressive Disease (PD)
|
4 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 1 (N = 8) Not Evaluable (NE)
|
1 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 2 (N = 14) Complete Response (CR)
|
0 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 2 (N = 14) Partial Response (PR)
|
1 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 2 (N = 14) Stable Disease (SD)
|
5 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 2 ( N = 14) Progressive Disease (PD)
|
4 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 3 ( N = 6) Partial Response (PR)
|
1 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 3 ( N = 6) Stable Disease (SD)
|
4 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 3 ( N = 6) Progressive Disease (PD)
|
0 Participants
|
|
Objective Response (as Determined Using RECIST 1.0 Criteria)
Dose Level 3 ( N = 6) Not Evaluable (NE)
|
1 Participants
|
Adverse Events
Treatment Group: Intravenous Topotecan and Oral Erlotinib
Serious events: 11 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group: Intravenous Topotecan and Oral Erlotinib
n=29 participants at risk
All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.3%
3/29 • Number of events 4 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Cardiac disorders
Pericardial Effusion
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Cardiac disorders
Sinus Tachycardia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Gastrointestinal Bleed
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • Number of events 3 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
2/29 • Number of events 3 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Chest Pain
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Death
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Fatigue
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Fatigue/Weakness
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Weakness
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Infected Venous Access
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Infection (Blood Cultures)
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Urinary Tract Infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Fever
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.3%
3/29 • Number of events 3 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Malnutrition
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Broken Right Clavicle
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain (related to broken right clavicle)
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Hematuria
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Hypotension
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Superior Vena Cava Syndrome
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
Other adverse events
| Measure |
Treatment Group: Intravenous Topotecan and Oral Erlotinib
n=29 participants at risk
All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
62.1%
18/29 • Number of events 43 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Leucytosis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.9%
2/29 • Number of events 4 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
51.7%
15/29 • Number of events 43 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
58.6%
17/29 • Number of events 40 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Cardiac disorders
Sinus Tachycardia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Ear and labyrinth disorders
Otitis Middle Ear
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Ear and labyrinth disorders
Pain in Ear
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Decreased Visual Focus
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Dry Eye Syndrome
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Itchy Eyes
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Teary Eyes
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Abdominal Cramps
|
3.4%
1/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Belching
|
3.4%
1/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Constipation
|
10.3%
3/29 • Number of events 3 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Decreased Bowel Sounds
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Diarrhea
|
37.9%
11/29 • Number of events 19 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Distended Abdomen
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Hematochezia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Heme Positive Stool
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Hiatal Hernia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Indigestion
|
3.4%
1/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Mouth Sores
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Mouth Tenderness
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Nausea
|
20.7%
6/29 • Number of events 9 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Tarry Stool
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Tenderness in Pelvic Area
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Tenderness in Right Quadrant
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Ulcerative Esophogitis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
4/29 • Number of events 5 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Chest Pain
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Chills
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Early Satiety
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Edema
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Edema - Bilateral Lower Extremity
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Edema - Bilateral Pedal
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Fatigue
|
37.9%
11/29 • Number of events 25 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Fever
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Nausea
|
13.8%
4/29 • Number of events 5 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Pain
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Pressure in Chest
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Rigors
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Swelling to Extremities
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Weakness
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Bacteremia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Cellulitis to Right Calf
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Gram Positive Bacilli
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Gram Positive Cocci Infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Infection - Skin Cellulitis
|
3.4%
1/29 • Number of events 4 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
MRSA - Abdomen
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
MRSA - Urine
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
MRSA - Blood
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Staph Infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Upper Respiratory Infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Urinary Tract Infection
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Vaginal Infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Yeast Candidiasis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Decreased Albumin
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Elevated ALT
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Elevated AST
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Elevated Bilirubin
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Elevated Creatinine
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Fever
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
High Platelet Count
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Low Grade Fever
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Temperature
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
17.2%
5/29 • Number of events 5 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.8%
4/29 • Number of events 4 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.4%
1/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
24.1%
7/29 • Number of events 16 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.3%
3/29 • Number of events 3 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Malnutrition
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Weight Loss
|
10.3%
3/29 • Number of events 4 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Achiness
|
3.4%
1/29 • Number of events 3 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Hip Pain
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
3.4%
1/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Right Knee Pain
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Right Rib Pain
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Agitation
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Altered Taste in Food
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Headache
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Lightheadedness
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Paresthesias Involving Bilateral Lower Extremities
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Right Foot Drop
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Weird Smells
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Confusion
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Depression
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Insomnia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Irritability/Mood Alteration
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Acute Renal Failure
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Anuria
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Azotemia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Bilateral Enlargement of Kidneys
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Chronic Renal Failure
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Dysuria
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Hypoproteinuria
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Low urine output
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar Hemorrhage
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Congestion
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.2%
5/29 • Number of events 5 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Decreased Pulmonary Expiration
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Nose Bleed
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Acidosis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Right Pleural Effusion
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Runny Nose
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
27.6%
8/29 • Number of events 10 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion/Cough
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Drainage
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Bleeding at Colostomy Site
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Facial Rash/Desquamation
|
3.4%
1/29 • Number of events 3 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Hand Foot Syndrome
|
3.4%
1/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Itching
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Itching/Burning (Neck)
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Itchy Scalp
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Itchy Skin (Neck)
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Peeling/Dry Skin (Forehead, Plams)
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash
|
48.3%
14/29 • Number of events 24 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash around Soft Skin of Both Eyes
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Seborrheic Dermatitis of Scalp
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Staph Epidermis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Facial Flushing
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Hypertension
|
6.9%
2/29 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Hypotension
|
3.4%
1/29 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
Additional Information
Vice President of Scientific Affairs
Accelerated Community Oncology Research Network, Inc.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER