Trial Outcomes & Findings for Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma (NCT NCT01211262)
NCT ID: NCT01211262
Last Updated: 2020-07-08
Results Overview
The maximum tolerated dose (MTD) for IMCgp100 administered by weekly dosing was determined based on the frequency of dose-limiting toxicity (DLT) occurring during Days 1 to 8. Participants presented at MTD in the dose escalation phase. Abbreviations: ng/kg=nanograms/kilogram
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
84 participants
Primary outcome timeframe
Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8
Results posted on
2020-07-08
Participant Flow
All-patients population and safety population both comprised 84 participants who enrolled in the study and who also received at least one IMCgp100 dose; the all-patients and safety population for Arm 1 was 66 participants and for Arm 2 was 18 participants. Efficacy population was 54 participants in Arm 1 and 15 participants in Arm 2.
Participant milestones
| Measure |
IMCgp100 Weekly Dosing Regimen
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
18
|
|
Overall Study
COMPLETED
|
43
|
8
|
|
Overall Study
NOT COMPLETED
|
23
|
10
|
Reasons for withdrawal
| Measure |
IMCgp100 Weekly Dosing Regimen
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Overall Study
Progressive Disease
|
18
|
9
|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Withdrawal of Consent
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma
Baseline characteristics by cohort
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 Participants
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
n=5 Participants
|
60.4 years
n=7 Participants
|
58.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
62 participants
n=5 Participants
|
17 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8Population: Safety population: all participants who received at least 1 dose of IMCgp100, up to a maximum of 600 ng/kg.
The maximum tolerated dose (MTD) for IMCgp100 administered by weekly dosing was determined based on the frequency of dose-limiting toxicity (DLT) occurring during Days 1 to 8. Participants presented at MTD in the dose escalation phase. Abbreviations: ng/kg=nanograms/kilogram
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=27 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) of IMCgp100 Administered Weekly (Dose Escalation Part)
|
600 ng/kg
|
—
|
PRIMARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8Population: Safety population: all participants who received at least 1 dose of IMCgp100
The MTD for IMCgp100 administered by daily dosing was determined based on the frequency of DLT occurring during Days 1 to 8. The 50 mcg dose was the RP2D for daily dosing, as the MTD was not achieved. Abbreviations: mcg=micrograms
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=18 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
MTD of IMCgp100 Administered Daily (Dose Escalation Part)
|
50 mcg
|
—
|
PRIMARY outcome
Timeframe: Day 1 (first dose), 30 days after the last dosePopulation: Safety Population
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) with an onset date after the date of first dose and within 30 days after the last administration of study medication in either treatment arm. AEs with missing date of onset were considered treatment emergent.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 Participants
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
|
100.0 percentage of participants
|
100.00 percentage of participants
|
PRIMARY outcome
Timeframe: 28 monthsPopulation: Safety Population
Laboratory parameters included clinical chemistry, hematology, and urinalysis. For hematology, this included red cell count, hemoglobin, hematocrit, mean cell volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, leukocyte differential count (percentage or absolute), prothrombin time, and activated partial tissue thromboplastin time. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 Participants
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Hematology)
Lymphocytes
|
12 number of participants
|
1 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Hematology)
Hemoglobin
|
1 number of participants
|
2 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Hematology)
Neutrophils
|
1 number of participants
|
0 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Hematology)
CD4 Cells
|
1 number of participants
|
0 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Hematology)
Leukocytes
|
1 number of participants
|
0 number of participants
|
PRIMARY outcome
Timeframe: 28 monthsPopulation: Safety Population
Laboratory parameters included clinical chemistry, hematology, and urinalysis. For hematology, this included red cell count, hemoglobin, hematocrit, mean cell volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, leukocyte differential count (percentage or absolute), prothrombin time, and activated partial tissue thromboplastin time. Laboratory parameter abnormalities were graded by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 at any time on treatment from normal pre-dose. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 Participants
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Hematology)
Lymphocytes-Grade 3
|
15 number of participants
|
2 number of participants
|
|
Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Hematology)
CD4 Count-Grade 3
|
4 number of participants
|
1 number of participants
|
|
Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Hematology)
Lymphocytes-Grade 4
|
2 number of participants
|
2 number of participants
|
|
Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Hematology)
CD4 Count-Grade 4
|
4 number of participants
|
1 number of participants
|
|
Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Hematology)
Hemoglobin-Grade 3
|
0 number of participants
|
3 number of participants
|
|
Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Hematology)
Leukocytes-Grade 3
|
1 number of participants
|
0 number of participants
|
PRIMARY outcome
Timeframe: 28 monthsPopulation: Safety Population
Laboratory parameters included clinical chemistry, hematology, and urinalysis. Clinical chemistry parameters included calcium, phosphorus, magnesium, albumin, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, lactate dehydrogenase, sodium, potassium, bicarbonate, creatinine, chloride, glucose, urea, uric acid, and C-reactive protein. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 Participants
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Clinical Chemistry)
Albumin
|
3 number of participants
|
3 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Clinical Chemistry)
Alkaline Phosphatase
|
3 number of participants
|
1 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Clinical Chemistry)
Aspartate Aminotransferase
|
1 number of participants
|
2 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Clinical Chemistry)
Alanine Aminotransferase
|
1 number of participants
|
1 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Clinical Chemistry)
Potassium
|
1 number of participants
|
1 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Clinical Chemistry)
Calcium
|
0 number of participants
|
1 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Clinical Chemistry)
Glucose
|
1 number of participants
|
0 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Clinical Chemistry)
Magnesium
|
0 number of participants
|
1 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Clinical Chemistry)
Sodium
|
0 number of participants
|
1 number of participants
|
|
Number of Participants Experiencing Clinically Significant Laboratory Parameters (Clinical Chemistry)
Uric Acid
|
1 number of participants
|
0 number of participants
|
PRIMARY outcome
Timeframe: 28 monthsPopulation: Safety Population
Laboratory parameters included clinical chemistry, hematology, and urinalysis. Clinical chemistry parameters included calcium, phosphorus, magnesium, albumin, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, lactate dehydrogenase, sodium, potassium, bicarbonate, creatinine, chloride, glucose, urea, uric acid, and C-reactive protein. Laboratory parameter abnormalities were graded by the investigator using CTCAE v 4.0 at any time on treatment from normal pre-dose. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 Participants
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Clinical Chemistry)
Sodium-Grade 3
|
2 number of participants
|
4 number of participants
|
|
Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Clinical Chemistry)
Potassium-Grade 3
|
2 number of participants
|
1 number of participants
|
|
Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Clinical Chemistry)
Glucose-Grade 3
|
1 number of participants
|
1 number of participants
|
|
Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Clinical Chemistry)
Aspartate Aminotransferase-Grade 3
|
1 number of participants
|
0 number of participants
|
|
Number of Participants Experiencing ≥Grade 3 Severity in Laboratory Parameters (Clinical Chemistry)
Calcium-Grade 3
|
0 number of participants
|
1 number of participants
|
PRIMARY outcome
Timeframe: 28 monthsPopulation: Safety Population
Twelve lead ECGs were obtained after the participant has rested in a supine position for at least 5 minutes. Clinically significant findings were defined as such in the opinion of the investigator or designated physician occurring at any time on treatment from normal pre-dose.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 Participants
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Number of Participants Experiencing Clinically Significant Electrocardiograms (ECGs)
|
3 number of participants
|
0 number of participants
|
PRIMARY outcome
Timeframe: 28 monthsPopulation: Safety Population
Vital signs included temperature, blood pressure, respiration rate, and heart rate. Measurements were made after the participant had been resting supine for a minimum of 5 minutes. Blood pressure and heart rate were measured using a recording device with an appropriate cuff size. Temperature and respiration rate were measured as per clinical practice. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 Participants
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Number of Participants Experiencing Clinically Significant Vital Signs
High Systolic Blood Pressure
|
17 number of participants
|
2 number of participants
|
|
Number of Participants Experiencing Clinically Significant Vital Signs
Low Systolic Blood Pressure
|
8 number of participants
|
5 number of participants
|
|
Number of Participants Experiencing Clinically Significant Vital Signs
High Diastolic Blood Pressure
|
20 number of participants
|
3 number of participants
|
|
Number of Participants Experiencing Clinically Significant Vital Signs
Low Diastolic Blood Pressure
|
37 number of participants
|
12 number of participants
|
|
Number of Participants Experiencing Clinically Significant Vital Signs
High Heart Rate
|
34 number of participants
|
12 number of participants
|
|
Number of Participants Experiencing Clinically Significant Vital Signs
Low Heart Rate
|
8 number of participants
|
1 number of participants
|
|
Number of Participants Experiencing Clinically Significant Vital Signs
High Temperature
|
33 number of participants
|
13 number of participants
|
PRIMARY outcome
Timeframe: 28 monthsPopulation: Safety Population
Physical examination included weight, a record of skin pigmentation, and photographic record of any vitiligo if present. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 Participants
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Number of Participants Experiencing Clinically Significant Physical Examination Results (Weight Decrease)
|
3 number of participants
|
1 number of participants
|
PRIMARY outcome
Timeframe: 28 monthsPopulation: Safety Population
Physical examination included weight, a record of skin pigmentation, and photographic record of any vitiligo if present. Abnormalities were graded by the investigator using CTCAE v 4.0 at any time on treatment from normal pre-dose. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 Participants
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Number of Participants Experiencing ≥Grade 3 Severity in Physical Examination Results (Skin Pigmentation)
|
0 number of participants
|
0 number of participants
|
SECONDARY outcome
Timeframe: 28 monthsPopulation: Efficacy population: only evaluable participants (those having both a baseline and post treatment sample).
The best overall response was assigned as complete response (CR), partial response (PR), minor response, stable disease, progressive disease (PD) or not evaluable (NE) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=54 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
n=15 Participants
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Number of Participants With Best Overall Response Per Response Evaluation Criteria In Solid Tumors (RECIST) (Weekly Dosing-Dose Expansion Part)
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 28 monthsPopulation: Efficacy population
To provide a comprehensive anti-drug antibody (ADA) summary for the study, individual participant data were combined and assessed as distinct groups based on characteristics of their ADA response. Evaluable participants were those with post-drug administration samples. ADA prevalence (pre- existing antibody response) was measured as the number of baseline-positive participant out of all participants who provided baseline samples. Overall ADA incidence was calculated based on the combined number of treatment-boosted and treatment-induced ADA-positive participants. The treatment-induced incidence was determined as the number of ADA- positive participants of those that were ADA-negative at baseline; while treatment-boosted incidence was determined as the number of participants with an ADA titer increase equal to or greater than the minimum significant dilution (3-fold) of the assay.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 Participants
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Number of Participants With Anti-IMCgp100 Antibody Formation (Dose Escalation and Dose Expansion Parts)
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1, Cycle 1Population: Pharmacokinetics (PK) Population: all participants who receive at least 1 dose of IMCgp100 and have at least 1 measurable PK concentration with the relevant date, time and dosing data for this sample.
The maximum plasma concentration (Cmax) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. Abbreviations: ng/kg = nanograms/kilogram
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=42 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Estimated Maximum Plasma Concentration (Cmax) of IMCgp100 By-weight Doses (Dose Escalation)
15 ng/kg by-weight dose
|
305.50 picograms/milliliter
Geometric Coefficient of Variation 583.47
|
—
|
|
Estimated Maximum Plasma Concentration (Cmax) of IMCgp100 By-weight Doses (Dose Escalation)
45 ng/kg by-weight dose
|
271.33 picograms/milliliter
Geometric Coefficient of Variation 21.49
|
—
|
|
Estimated Maximum Plasma Concentration (Cmax) of IMCgp100 By-weight Doses (Dose Escalation)
135 ng/kg by-weight dose
|
371.79 picograms/milliliter
Geometric Coefficient of Variation 57.25
|
—
|
|
Estimated Maximum Plasma Concentration (Cmax) of IMCgp100 By-weight Doses (Dose Escalation)
270 ng/kg by-weight dose
|
856.35 picograms/milliliter
Geometric Coefficient of Variation 41.01
|
—
|
|
Estimated Maximum Plasma Concentration (Cmax) of IMCgp100 By-weight Doses (Dose Escalation)
405 ng/kg by-weight dose
|
2345.25 picograms/milliliter
Geometric Coefficient of Variation 35.74
|
—
|
|
Estimated Maximum Plasma Concentration (Cmax) of IMCgp100 By-weight Doses (Dose Escalation)
600 ng/kg by-weight dose
|
6188.54 picograms/milliliter
Geometric Coefficient of Variation 41.21
|
—
|
|
Estimated Maximum Plasma Concentration (Cmax) of IMCgp100 By-weight Doses (Dose Escalation)
900 ng/kg by-weight dose
|
8868.83 picograms/milliliter
Geometric Coefficient of Variation 27.92
|
—
|
SECONDARY outcome
Timeframe: Day 1, Cycle 1Population: PK Population
The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=4 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Estimated Cmax of IMCgp100 of 900 ng/kg By-weight Dose (Dose Escalation and Dose Expansion Parts)
|
8868.83 picograms/milliliter
Geometric Coefficient of Variation 27.92
|
—
|
SECONDARY outcome
Timeframe: Day 1, Cycle 1Population: PK Population
The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. Abbreviations: mcg = micrograms
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=21 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Estimated Cmax of IMCgp100 Flat Dose (Dose Escalation and Dose Expansion Parts)
20 mcg
|
3239.82 picograms/milliliter
Geometric Coefficient of Variation 20.97
|
—
|
|
Estimated Cmax of IMCgp100 Flat Dose (Dose Escalation and Dose Expansion Parts)
40 mcg
|
8316.43 picograms/milliliter
Geometric Coefficient of Variation 45.10
|
—
|
|
Estimated Cmax of IMCgp100 Flat Dose (Dose Escalation and Dose Expansion Parts)
50 mcg
|
8740.99 picograms/milliliter
Geometric Coefficient of Variation 38.01
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50Population: PK Population
The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=10 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Estimated Cmax of IMCgp100 of 600 ng/kg By-weight Dose (Dose Escalation)
Day 1
|
7311 picograms/milliliter
Standard Deviation 1770
|
—
|
|
Estimated Cmax of IMCgp100 of 600 ng/kg By-weight Dose (Dose Escalation)
Day 8
|
5726 picograms/milliliter
Standard Deviation 3605
|
—
|
|
Estimated Cmax of IMCgp100 of 600 ng/kg By-weight Dose (Dose Escalation)
Day 15
|
6182 picograms/milliliter
Standard Deviation 1456
|
—
|
|
Estimated Cmax of IMCgp100 of 600 ng/kg By-weight Dose (Dose Escalation)
Day 22
|
6490 picograms/milliliter
Standard Deviation 2488
|
—
|
|
Estimated Cmax of IMCgp100 of 600 ng/kg By-weight Dose (Dose Escalation)
Day 29
|
6245 picograms/milliliter
Standard Deviation 3047
|
—
|
|
Estimated Cmax of IMCgp100 of 600 ng/kg By-weight Dose (Dose Escalation)
Day 36
|
6396 picograms/milliliter
Standard Deviation 3474
|
—
|
|
Estimated Cmax of IMCgp100 of 600 ng/kg By-weight Dose (Dose Escalation)
Day 43
|
6014 picograms/milliliter
Standard Deviation 1125
|
—
|
|
Estimated Cmax of IMCgp100 of 600 ng/kg By-weight Dose (Dose Escalation)
Day 50
|
7136 picograms/milliliter
Standard Deviation 2744
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50Population: PK Population
The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. On Day 1, IMCgp100 20 mcg was given, IMCgp100 30 mcg was administered on Day 8, and IMCgp100 50 mcg was dosed on Days 15 and after.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=7 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Estimated Cmax of IMCgp100 of 20/30/50 mcg Flat Dose (Dose Escalation)
Day 1
|
3299 mcg
Standard Deviation 660
|
—
|
|
Estimated Cmax of IMCgp100 of 20/30/50 mcg Flat Dose (Dose Escalation)
Day 8
|
5056 mcg
Standard Deviation 1175
|
—
|
|
Estimated Cmax of IMCgp100 of 20/30/50 mcg Flat Dose (Dose Escalation)
Day 15
|
7981 mcg
Standard Deviation 2278
|
—
|
|
Estimated Cmax of IMCgp100 of 20/30/50 mcg Flat Dose (Dose Escalation)
Day 22
|
6682 mcg
Standard Deviation 1395
|
—
|
|
Estimated Cmax of IMCgp100 of 20/30/50 mcg Flat Dose (Dose Escalation)
Day 29
|
4710 mcg
Standard Deviation 3621
|
—
|
|
Estimated Cmax of IMCgp100 of 20/30/50 mcg Flat Dose (Dose Escalation)
Day 36
|
7100 mcg
Standard Deviation 1535
|
—
|
|
Estimated Cmax of IMCgp100 of 20/30/50 mcg Flat Dose (Dose Escalation)
Day 43
|
7240 mcg
Standard Deviation 1906
|
—
|
|
Estimated Cmax of IMCgp100 of 20/30/50 mcg Flat Dose (Dose Escalation)
Day 50
|
6658 mcg
Standard Deviation 1211
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50Population: PK Population
The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. This dosing regimen was implemented following the Urgent Safety Measure to adapt the dosing in the Phase 1 study that dropped Dose 1 to 40 mcg from the identified 50 mcg RP2D.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=3 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Estimated Cmax of IMCgp100 of 40/40/50 mcg Flat Dose (Dose Escalation)
Day 1
|
8847 mcg
Standard Deviation 3811
|
—
|
|
Estimated Cmax of IMCgp100 of 40/40/50 mcg Flat Dose (Dose Escalation)
Day 8
|
5340 mcg
Standard Deviation 311
|
—
|
|
Estimated Cmax of IMCgp100 of 40/40/50 mcg Flat Dose (Dose Escalation)
Day 15
|
8373 mcg
Standard Deviation 2682
|
—
|
|
Estimated Cmax of IMCgp100 of 40/40/50 mcg Flat Dose (Dose Escalation)
Day 22
|
7445 mcg
Standard Deviation 983
|
—
|
|
Estimated Cmax of IMCgp100 of 40/40/50 mcg Flat Dose (Dose Escalation)
Day 29
|
3288 mcg
Standard Deviation 4614
|
—
|
|
Estimated Cmax of IMCgp100 of 40/40/50 mcg Flat Dose (Dose Escalation)
Day 36
|
8073 mcg
Standard Deviation 1337
|
—
|
|
Estimated Cmax of IMCgp100 of 40/40/50 mcg Flat Dose (Dose Escalation)
Day 43
|
6735 mcg
Standard Deviation 672
|
—
|
|
Estimated Cmax of IMCgp100 of 40/40/50 mcg Flat Dose (Dose Escalation)
Day 50
|
7130 mcg
Standard Deviation 4483
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50Population: PK Population
The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The RP2D identified in this study following review of all safety and pharmacokinetic data in the dose escalation of the Phase 1 study was the 50 mcg flat dose.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=11 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Estimated Cmax of IMCgp100 of 50 mcg Flat Dose (Dose Escalation)
Day 1
|
9327 mcg
Standard Deviation 3802
|
—
|
|
Estimated Cmax of IMCgp100 of 50 mcg Flat Dose (Dose Escalation)
Day 8
|
6414 mcg
Standard Deviation 3653
|
—
|
|
Estimated Cmax of IMCgp100 of 50 mcg Flat Dose (Dose Escalation)
Day 15
|
7236 mcg
Standard Deviation 3304
|
—
|
|
Estimated Cmax of IMCgp100 of 50 mcg Flat Dose (Dose Escalation)
Day 22
|
7620 mcg
Standard Deviation 2710
|
—
|
|
Estimated Cmax of IMCgp100 of 50 mcg Flat Dose (Dose Escalation)
Day 29
|
8186 mcg
Standard Deviation 3178
|
—
|
|
Estimated Cmax of IMCgp100 of 50 mcg Flat Dose (Dose Escalation)
Day 36
|
8425 mcg
Standard Deviation 4594
|
—
|
|
Estimated Cmax of IMCgp100 of 50 mcg Flat Dose (Dose Escalation)
Day 43
|
6905 mcg
Standard Deviation 4097
|
—
|
|
Estimated Cmax of IMCgp100 of 50 mcg Flat Dose (Dose Escalation)
Day 50
|
9018 mcg
Standard Deviation 5001
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Day 1Population: PK Population
The Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=18 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Estimated Cmax of IMCgp100 of a Single Infusion Flat Dose (Dose Escalation)
10 mcg
|
997.83 picograms/milliliter
Geometric Coefficient of Variation 38.01
|
—
|
|
Estimated Cmax of IMCgp100 of a Single Infusion Flat Dose (Dose Escalation)
20 mcg
|
3599.18 picograms/milliliter
Geometric Coefficient of Variation 15.42
|
—
|
|
Estimated Cmax of IMCgp100 of a Single Infusion Flat Dose (Dose Escalation)
30 mcg
|
3599.18 picograms/milliliter
Geometric Coefficient of Variation 15.42
|
—
|
|
Estimated Cmax of IMCgp100 of a Single Infusion Flat Dose (Dose Escalation)
40 mcg
|
6157.90 picograms/milliliter
Geometric Coefficient of Variation 29.52
|
—
|
|
Estimated Cmax of IMCgp100 of a Single Infusion Flat Dose (Dose Escalation)
50 mcg
|
8111.79 picograms/milliliter
Geometric Coefficient of Variation 27.80
|
—
|
SECONDARY outcome
Timeframe: Day 1, Cycle 1Population: PK Population
The area under the concentration-time curve (AUC), measured in hours by picograms per milliliter ( h\*pg/ml) is a method of measurement of the total exposure of a drug in blood.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=42 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
Area Under the Concentration-Time Curve (AUC) of IMCgp100 By-weight Dose (Dose Escalation)
15 ng/kg
|
5666.63 hours * picograms/milliliter
Geometric Coefficient of Variation 434.62
|
—
|
|
Area Under the Concentration-Time Curve (AUC) of IMCgp100 By-weight Dose (Dose Escalation)
45 ng/kg
|
2965.10 hours * picograms/milliliter
Geometric Coefficient of Variation 49.17
|
—
|
|
Area Under the Concentration-Time Curve (AUC) of IMCgp100 By-weight Dose (Dose Escalation)
135 ng/kg
|
2904.91 hours * picograms/milliliter
Geometric Coefficient of Variation 96.95
|
—
|
|
Area Under the Concentration-Time Curve (AUC) of IMCgp100 By-weight Dose (Dose Escalation)
270 ng/kg
|
10649.19 hours * picograms/milliliter
Geometric Coefficient of Variation 40.82
|
—
|
|
Area Under the Concentration-Time Curve (AUC) of IMCgp100 By-weight Dose (Dose Escalation)
405 ng/kg
|
33332.31 hours * picograms/milliliter
Geometric Coefficient of Variation 43.57
|
—
|
|
Area Under the Concentration-Time Curve (AUC) of IMCgp100 By-weight Dose (Dose Escalation)
600 ng/kg
|
63507.24 hours * picograms/milliliter
Geometric Coefficient of Variation 43.97
|
—
|
|
Area Under the Concentration-Time Curve (AUC) of IMCgp100 By-weight Dose (Dose Escalation)
900 ng/kg
|
97724.58 hours * picograms/milliliter
Geometric Coefficient of Variation 29.49
|
—
|
SECONDARY outcome
Timeframe: Day 1, Cycle 1Population: PK Population
The AUC, measured in h\*pg/ml, is a method of measurement of the total exposure of a drug in blood.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=4 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
AUC of IMCgp100 of 900 ng/kg By-weight Dose (Dose Escalation and Dose Expansion Parts)
|
97724.58 hours * picograms/milliliter
Geometric Coefficient of Variation 29.49
|
—
|
SECONDARY outcome
Timeframe: Day 1, Cycle 1Population: PK Population
The AUC (measured in h\*pg/ml) is a method of measurement of the total exposure of a drug in blood. Participants in the 20 mcg and 40 mcg dose groups received intra-participant dose-escalation up to 50 mcg on Day 15.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=10 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
AUC of IMCgp100 Flat Dose (Dose Escalation and Dose Expansion Parts)
20 mcg
|
3239.82 hours * picograms/milliliter
Geometric Coefficient of Variation 20.97
|
—
|
|
AUC of IMCgp100 Flat Dose (Dose Escalation and Dose Expansion Parts)
40 mcg
|
59333.15 hours * picograms/milliliter
Geometric Coefficient of Variation 21.44
|
—
|
SECONDARY outcome
Timeframe: Day 1, Cycle 1Population: PK Population
The AUC (measured in h\*pg/ml) is a method of measurement of the total exposure of a drug in blood.
Outcome measures
| Measure |
IMCgp100 Weekly Dosing Regimen
n=11 Participants
Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each.
|
IMCgp100 Daily Dosing Regimen
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
|
|---|---|---|
|
AUC of IMCgp100 of 50 mcg Flat Dose (Dose Escalation and Dose Expansion Parts)
|
73134.57 hours * picograms/milliliter
Geometric Coefficient of Variation 55.88
|
—
|
Adverse Events
IMCgp100 Weekly Dosing Regimen
Serious events: 24 serious events
Other events: 66 other events
Deaths: 8 deaths
IMCgp100 Daily Dosing Regimen
Serious events: 5 serious events
Other events: 18 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 participants at risk
Weekly intravenous (IV) infusions of IMCgp100 at the weekly maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) over treatment cycles of eight weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 participants at risk
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six week treatment cycle at the MTD/daily RP2D.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Gastrointestinal disorders
ASCITES
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Gastrointestinal disorders
INTRA-ABDOMINAL HAEMORRHAGE
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
ADVERSE DRUG REACTION
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
DISEASE PROGRESSION
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
MALAISE
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
PYREXIA
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Immune system disorders
CYTOKINE RELEASE SYNDROME
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
BILIARY TRACT INFECTION
|
1.5%
1/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
CONJUNCTIVITIS
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
GASTRIC INFECTION
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Investigations
LABORATORY TEST ABNORMAL
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Investigations
LIVER FUNCTION TEST INCREASED
|
3.0%
2/66 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGE
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Nervous system disorders
APHASIA
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
RASH
|
1.5%
1/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Vascular disorders
HYPOTENSION
|
6.1%
4/66 • Number of events 5 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
Other adverse events
| Measure |
IMCgp100 Weekly Dosing Regimen
n=66 participants at risk
Weekly intravenous (IV) infusions of IMCgp100 at the weekly maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) over treatment cycles of eight weeks each.
|
IMCgp100 Daily Dosing Regimen
n=18 participants at risk
Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six week treatment cycle at the MTD/daily RP2D.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.1%
4/66 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
27.8%
5/18 • Number of events 5 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
4.5%
3/66 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
19.7%
13/66 • Number of events 13 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
22.2%
4/18 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
7.6%
5/66 • Number of events 5 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Cardiac disorders
TACHYCARDIA
|
10.6%
7/66 • Number of events 7 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
22.2%
4/18 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Eye disorders
ERYTHEMA OF EYELID
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Eye disorders
EYE IRRITATION
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Eye disorders
EYE PAIN
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Eye disorders
EYELID OEDEMA
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Eye disorders
OCULAR HYPERAEMIA
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Eye disorders
PERIORBITAL OEDEMA
|
45.5%
30/66 • Number of events 30 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
61.1%
11/18 • Number of events 11 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
13.6%
9/66 • Number of events 9 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
7.6%
5/66 • Number of events 5 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Gastrointestinal disorders
CONSTIPATION
|
21.2%
14/66 • Number of events 14 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
16.7%
3/18 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Gastrointestinal disorders
DIARRHOEA
|
15.2%
10/66 • Number of events 10 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
27.8%
5/18 • Number of events 5 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.1%
4/66 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Gastrointestinal disorders
NAUSEA
|
51.5%
34/66 • Number of events 34 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
55.6%
10/18 • Number of events 10 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Gastrointestinal disorders
VOMITING
|
36.4%
24/66 • Number of events 24 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
55.6%
10/18 • Number of events 10 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
ASTHENIA
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
AXILLARY PAIN
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
CHEST PAIN
|
10.6%
7/66 • Number of events 7 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
CHILLS
|
25.8%
17/66 • Number of events 17 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
50.0%
9/18 • Number of events 9 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
FACE OEDEMA
|
19.7%
13/66 • Number of events 13 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
16.7%
3/18 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
FATIGUE
|
53.0%
35/66 • Number of events 35 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
55.6%
10/18 • Number of events 10 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
19.7%
13/66 • Number of events 13 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
27.8%
5/18 • Number of events 5 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
MALAISE
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
OEDEMA
|
6.1%
4/66 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
OEDEMA PERIPHERAL
|
15.2%
10/66 • Number of events 10 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
44.4%
8/18 • Number of events 8 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
PAIN
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
PERIPHERAL SWELLING
|
9.1%
6/66 • Number of events 6 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
General disorders
PYREXIA
|
51.5%
34/66 • Number of events 34 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
72.2%
13/18 • Number of events 13 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Immune system disorders
HYPERSENSITIVITY
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
ANGULAR CHEILITIS
|
6.1%
4/66 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
CONJUNCTIVITIS
|
7.6%
5/66 • Number of events 5 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
4.5%
3/66 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
RASH PUSTULAR
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
RHINITIS
|
9.1%
6/66 • Number of events 6 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.1%
4/66 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.1%
4/66 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
4.5%
3/66 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Investigations
BLOOD CREATININE INCREASED
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Investigations
TRANSAMINASES INCREASED
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
16.7%
3/18 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Investigations
WEIGHT DECREASED
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
13.6%
9/66 • Number of events 9 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
6.1%
4/66 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
4.5%
3/66 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
7.6%
5/66 • Number of events 5 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
16.7%
3/18 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Metabolism and nutrition disorders
HYPOPROTEINAEMIA
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.6%
7/66 • Number of events 7 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
16.7%
3/18 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
21.2%
14/66 • Number of events 14 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
4.5%
3/66 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
9.1%
6/66 • Number of events 6 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
4.5%
3/66 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
13.6%
9/66 • Number of events 9 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Nervous system disorders
DIZZINESS
|
6.1%
4/66 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Nervous system disorders
HEADACHE
|
24.2%
16/66 • Number of events 16 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
33.3%
6/18 • Number of events 6 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Nervous system disorders
LETHARGY
|
7.6%
5/66 • Number of events 5 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Nervous system disorders
PARAESTHESIA
|
15.2%
10/66 • Number of events 10 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Nervous system disorders
SPEECH DISORDER
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Psychiatric disorders
HALLUCINATION
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Psychiatric disorders
INSOMNIA
|
6.1%
4/66 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Renal and urinary disorders
POLLAKIURIA
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
24.2%
16/66 • Number of events 16 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
9.1%
6/66 • Number of events 6 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
4.5%
3/66 • Number of events 3 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.1%
4/66 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Respiratory, thoracic and mediastinal disorders
RALES
|
6.1%
4/66 • Number of events 4 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
0.00%
0/18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
BLOOD BLISTER
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
COLD SWEAT
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
27.3%
18/66 • Number of events 18 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
27.8%
5/18 • Number of events 5 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
25.8%
17/66 • Number of events 17 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
11.1%
2/18 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
GENERALISED ERYTHEMA
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
HAIR COLOUR CHANGES
|
10.6%
7/66 • Number of events 7 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
ONYCHOCLASIS
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
65.2%
43/66 • Number of events 43 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
88.9%
16/18 • Number of events 16 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
RASH
|
71.2%
47/66 • Number of events 47 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
55.6%
10/18 • Number of events 10 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
13.6%
9/66 • Number of events 9 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
27.8%
5/18 • Number of events 5 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
1.5%
1/66 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
25.8%
17/66 • Number of events 17 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
33.3%
6/18 • Number of events 6 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
3.0%
2/66 • Number of events 2 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
28.8%
19/66 • Number of events 19 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
27.8%
5/18 • Number of events 5 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Skin and subcutaneous tissue disorders
VITILIGO
|
13.6%
9/66 • Number of events 9 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Vascular disorders
FLUSHING
|
16.7%
11/66 • Number of events 11 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Vascular disorders
HAEMORRHAGE
|
0.00%
0/66 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Vascular disorders
HYPERTENSION
|
10.6%
7/66 • Number of events 7 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
5.6%
1/18 • Number of events 1 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
|
Vascular disorders
HYPOTENSION
|
30.3%
20/66 • Number of events 20 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
38.9%
7/18 • Number of events 7 • Up to Day 80 (follow up)
Adverse events were recorded from the time informed consent was obtained to 30 days after the final dose or 30 days after withdrawal from treatment. The safety population was comprised of the 84 participants who enrolled in the study and included all participants who received at least one dose of IMCgp100.
|
Additional Information
Chris Holland, Executive Director Head of Biostatistics
Immunocore, LLC
Phone: 1-267-589-9204
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publication/presentation (manuscript, abstract or poster) to a journal/scientific meeting is sent to sponsor for review at least 1 month before submission who may delay submission by up to 90 days if it reasonably believes that publication of results may compromise its intellectual property rights or else insist that such data are removed. No single center/groups of centers may publish individually. Publication will not include confidential information without the permission of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER