Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00073749
Collaborator
(none)
79
22
1
88
3.6
0
Study Details
Study Description
Brief Summary
To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
79 participants
Allocation:
Non-Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma
Actual Study Start Date
:
Aug 1, 2003
Actual Primary Completion Date
:
Dec 1, 2010
Actual Study Completion Date
:
Dec 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Inotuzumab ozogamicin Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2 |
Drug: Inotuzumab ozogamicin [CMC-544]
CMC-544, IV, dose escalation trial
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 42 days after last dose of study drug (up to Day 225)]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAE) are defined as any new event reported after first dose of study drug up to 42 days after last dose of study drug, or any event that is worse in severity than at any time during the baseline period. AEs included both SAEs and non-serious adverse events (non-SAEs).
- Number of Participants With Grade 3 or Higher Grades Treatment-Emergent Adverse Events (TEAEs) Based on Severity [Baseline up to 42 days after last dose of study drug (up to Day 225)]
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE severity was defined to be the maximum toxicity grade of the treatment-emergent adverse events (TEAEs) experienced by the participants during the study. AE was assessed according to severity; Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening or disabling AE), Grade 5 (death related to AE). Participants with Grade 3 or higher grades TEAEs were reported.
- Maximum Tolerated Dose (MTD): Part 1 (Dose Escalation Cohorts) [Baseline up to Day 28]
MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT). DLT was defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 2 weeks.
- Number of Participants With Dose-limiting Toxicity (DLT) [Baseline up to Day 28]
DLT was classified as per National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 3.0 and defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 14 days.
Secondary Outcome Measures
- Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts) [Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)]
PFS was based on Kaplan-Meier estimates. PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per the International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
- Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts) [Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)]
PFS was based on Kaplan-Meier estimates. PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
- Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts) [Baseline up to Year 5]
OS was based on Kaplan-Meier method. Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
- Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts) [Baseline up to Year 5]
Interval OS was based on Kaplan-Meier method. Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
- Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts) [Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)]
Participants with BOR=with complete response(CR),unconfirmed CR(CRu) or partial response (PR) as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical,radiographic sign of disease/related symptoms,normalization biochemical abnormalities related to NHL;if enlarged before therapy all lymph nodes,nodal masses,other organs regressed to normal size and spleen regressed in size,undetectable on physical exam,clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR:>=50% decrease in sum of products of greatest diameters(SPD) of 6 largest dominant nodes/nodal masses,no increase in size of other nodes/spleen/liver, 50% decrease in SPD of splenic,hepatic nodules,involvement of other organs considered assessable,not measurable disease with exception of splenic,hepatic nodules.
- Duration of Overall Response (DoR): Part 2 (Lead-in + Expanded Cohorts) [Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)]
Duration of overall response was defined as the time from the date that measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the first date that relapsed disease was objectively documented as per International Response Criteria for NHL, taking as reference for relapsed disease the smallest measurements recorded since the treatment started. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
- Time-to-Tumor Progression: Part 2 (Expanded Cohorts) [Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)]
Time to tumor progression was defined as the interval from the start of the treatment until the first date on which relapsed disease or progression is documented, censored at the last disease assessment. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Other Outcome Measures
- Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts) [Baseline up to 42 days after last dose (Day 225)]
Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.
- Percentage of Participants With Objective Response- Intent-to-treat Population: Part 2 (Lead in+ Expanded Cohorts) [Baseline up to 42 days after last dose of study drug (Day 225)]
Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
-
At the expanded cohort, part 2 of the study, subjects must have one of the following:
-
Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
-
Diffuse large B-cell lymphoma
-
Age 18 years or older
Exclusion Criteria:
-
Candidate for potentially curative therapies in the opinion of the investigator
-
Chronic lymphocytic leukemia
-
Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UAB CCC Clinical Studies Unit | Birmingham | Alabama | United States | 35233 |
| 2 | University of Alabama at Birmingham Kirklin Clinic | Birmingham | Alabama | United States | 35233 |
| 3 | UAB Russell Ambulatory Pharmacy | Birmingham | Alabama | United States | 35294 |
| 4 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 5 | Northwestern Medical Faculty Foundation | Chicago | Illinois | United States | 60611 |
| 6 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
| 7 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 8 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 9 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 10 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 11 | M.D. Anderson Cancer Center | Houston | Texas | United States | 77030-4009 |
| 12 | Universitair Ziekenhuis Gasthuisberg | Leuven | Belgium | 3000 | |
| 13 | Hopital Saint Louis | Paris | France | 75010 | |
| 14 | Centre Hospitalier Lyon-Sud | Pierre Benite Cedex | France | 69495 | |
| 15 | Universitätsklinikum Bonn | Bonn | NRW | Germany | 53105 |
| 16 | Universitaetsmedizin der Johannes Gutenberg-Universitaet | Mainz | Germany | 55131 | |
| 17 | Medizinische Klinik und Poliklinik III, Klinikum der Universitat Muenchen-Grosshadern | Muenchen | Germany | 81377 | |
| 18 | Universitaet Muenchen Klinikum Grosshadern | Muenchen | Germany | 81377 | |
| 19 | Hospital de la Santa Creu I Sant Pau | Barcelona | Spain | 08025 | |
| 20 | Hospital Clinic I Provincial | Barcelona | Spain | 08036 | |
| 21 | Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | 1011 | |
| 22 | St Bartholomew's Hospital | London | United Kingdom | EC1A 7BE |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00073749
Other Study ID Numbers:
- 3129K1-100
- B1931002
First Posted:
Dec 5, 2003
Last Update Posted:
Dec 17, 2018
Last Verified:
Dec 1, 2018
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | The study was conducted in 2 parts. Part 1: Dose escalation cohorts of inotuzumab ozogamicin to determine the maximum tolerated dose (MTD) included 21 days and 28 days dose administration cycles. Part 2: Expanded cohort using the MTD regimen identified in Part 1. |
| Arm/Group Title | Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1 | Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2 | Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3 | Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4 | Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5 | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort | Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 0.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.34 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 2.4 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Period Title: Overall Study | |||||||
| STARTED | 2 | 5 | 11 | 6 | 6 | 6 | 43 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| NOT COMPLETED | 2 | 5 | 11 | 6 | 6 | 6 | 40 |
Baseline Characteristics
| Arm/Group Title | Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1 | Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2 | Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3 | Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4 | Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5 | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort | Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 0.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.34 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 2.4 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. | Total of all reporting groups |
| Overall Participants | 2 | 5 | 11 | 6 | 6 | 6 | 43 | 79 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [years] |
50.50
(13.44)
|
73.80
(2.59)
|
65.45
(10.56)
|
56.67
(5.96)
|
60.00
(12.82)
|
57.17
(12.25)
|
57.30
(10.91)
|
59.46
(11.29)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
0
0%
|
2
40%
|
4
36.4%
|
0
0%
|
1
16.7%
|
2
33.3%
|
23
53.5%
|
32
40.5%
|
| Male |
2
100%
|
3
60%
|
7
63.6%
|
6
100%
|
5
83.3%
|
4
66.7%
|
20
46.5%
|
47
59.5%
|
Outcome Measures
| Title | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
|---|---|
| Description | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAE) are defined as any new event reported after first dose of study drug up to 42 days after last dose of study drug, or any event that is worse in severity than at any time during the baseline period. AEs included both SAEs and non-serious adverse events (non-SAEs). |
| Time Frame | Baseline up to 42 days after last dose of study drug (up to Day 225) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin. |
| Arm/Group Title | Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5 | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts |
|---|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Measure Participants | 30 | 49 |
| AEs |
29
1450%
|
49
980%
|
| SAEs |
11
550%
|
15
300%
|
| Title | Number of Participants With Grade 3 or Higher Grades Treatment-Emergent Adverse Events (TEAEs) Based on Severity |
|---|---|
| Description | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE severity was defined to be the maximum toxicity grade of the treatment-emergent adverse events (TEAEs) experienced by the participants during the study. AE was assessed according to severity; Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening or disabling AE), Grade 5 (death related to AE). Participants with Grade 3 or higher grades TEAEs were reported. |
| Time Frame | Baseline up to 42 days after last dose of study drug (up to Day 225) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin. |
| Arm/Group Title | Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5 | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts |
|---|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Measure Participants | 30 | 49 |
| Number [participants] |
24
1200%
|
42
840%
|
| Title | Maximum Tolerated Dose (MTD): Part 1 (Dose Escalation Cohorts) |
|---|---|
| Description | MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT). DLT was defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 2 weeks. |
| Time Frame | Baseline up to Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin. This outcome measure was not planned to be analyzed in Part 2 of the study. |
| Arm/Group Title | Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5 |
|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell NHL received either 0.4, 0.8, 1.34, 1.8 or 2.4 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. |
| Measure Participants | 30 |
| Number [milligram per meter square (mg/m^2)] |
1.8
|
| Title | Number of Participants With Dose-limiting Toxicity (DLT) |
|---|---|
| Description | DLT was classified as per National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 3.0 and defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 14 days. |
| Time Frame | Baseline up to Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin. Here number of participant analyzed (N) signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1 | Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2 | Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3 | Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4 | Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5 | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 0.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.34 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 2.4 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Measure Participants | 2 | 5 | 11 | 6 | 6 | 6 |
| Number [participants] |
0
0%
|
0
0%
|
2
18.2%
|
1
16.7%
|
2
33.3%
|
0
0%
|
| Title | Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts) |
|---|---|
| Description | PFS was based on Kaplan-Meier estimates. PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per the International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma. |
| Time Frame | Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population: All participants who received at least 2 doses of study drug, had baseline tumor computed tomography (CT) scan, and at least 1 post-baseline tumor assessment for anti-cancer clinical activity. Here 'N' represents number of participants evaluable for this outcome measure. This was not planned to be analyzed in Part 1 of study. |
| Arm/Group Title | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts |
|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Measure Participants | 35 |
| With Diffuse Lymphoma |
103
|
| With Follicular Lymphoma |
311
|
| Title | Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts) |
|---|---|
| Description | PFS was based on Kaplan-Meier estimates. PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma. |
| Time Frame | Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population included all enrolled participants. Here 'N' represents number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study. |
| Arm/Group Title | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts |
|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Measure Participants | 48 |
| With Diffuse Lymphoma |
49.5
|
| With Follicular Lymphoma |
254
|
| Title | Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts) |
|---|---|
| Description | OS was based on Kaplan-Meier method. Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma. |
| Time Frame | Baseline up to Year 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population: All participants who received at least 2 doses of study drug, had baseline tumor CT scan, and at least 1 post-baseline tumor assessment for anti-cancer clinical activity. Here 'N' represents number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of study. |
| Arm/Group Title | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts |
|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Measure Participants | 35 |
| With Diffuse Lymphoma |
274
|
| With Follicular Lymphoma |
NA
|
| Title | Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts) |
|---|---|
| Description | Interval OS was based on Kaplan-Meier method. Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma. |
| Time Frame | Baseline up to Year 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all enrolled participants. Here 'N' signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study. |
| Arm/Group Title | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts |
|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Measure Participants | 48 |
| With Diffuse Lymphoma |
194
|
| With Follicular Lymphoma |
1147
|
| Title | Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts) |
|---|---|
| Description | Participants with BOR=with complete response(CR),unconfirmed CR(CRu) or partial response (PR) as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical,radiographic sign of disease/related symptoms,normalization biochemical abnormalities related to NHL;if enlarged before therapy all lymph nodes,nodal masses,other organs regressed to normal size and spleen regressed in size,undetectable on physical exam,clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR:>=50% decrease in sum of products of greatest diameters(SPD) of 6 largest dominant nodes/nodal masses,no increase in size of other nodes/spleen/liver, 50% decrease in SPD of splenic,hepatic nodules,involvement of other organs considered assessable,not measurable disease with exception of splenic,hepatic nodules. |
| Time Frame | Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population was analyzed. Participants with diffuse or follicular lymphoma were analyzed. This outcome measure was not planned to be analyzed in Part 1 and Part 2 (Lead-in Cohort). |
| Arm/Group Title | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts |
|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Measure Participants | 30 |
| CR: With Follicular Lymphoma |
1
50%
|
| CR: With Diffuse Lymphoma |
2
100%
|
| CRu: With Follicular Lymphoma |
3
150%
|
| CRu: With Diffuse Lymphoma |
0
0%
|
| PR: With Follicular Lymphoma |
8
400%
|
| PR: With Diffuse Lymphoma |
5
250%
|
| Title | Duration of Overall Response (DoR): Part 2 (Lead-in + Expanded Cohorts) |
|---|---|
| Description | Duration of overall response was defined as the time from the date that measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the first date that relapsed disease was objectively documented as per International Response Criteria for NHL, taking as reference for relapsed disease the smallest measurements recorded since the treatment started. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma. |
| Time Frame | Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population was analyzed. DoR included evaluable participants who achieved CR, CRu, or PR. Here 'N' signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study. |
| Arm/Group Title | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts |
|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Measure Participants | 22 |
| With Diffuse Lymphoma |
80.00
|
| With Follicular Lymphoma |
233.0
|
| Title | Time-to-Tumor Progression: Part 2 (Expanded Cohorts) |
|---|---|
| Description | Time to tumor progression was defined as the interval from the start of the treatment until the first date on which relapsed disease or progression is documented, censored at the last disease assessment. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma. |
| Time Frame | Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population was analyzed. Here "N" signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 and Part 2 (Lead-in Cohort) of the study. |
| Arm/Group Title | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts |
|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Measure Participants | 30 |
| With Diffuse Lymphoma |
105
|
| With Follicular Lymphoma |
339
|
| Title | Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts) |
|---|---|
| Description | Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules. |
| Time Frame | Baseline up to 42 days after last dose (Day 225) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population: All participants who received at least 2 doses of study drug, had baseline tumor CT scan, and at least 1 post-baseline tumor assessment for anti-cancer clinical activity. Here 'N' represents number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of study. |
| Arm/Group Title | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts |
|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Measure Participants | 35 |
| With Diffuse Lymphoma |
25
1250%
|
| With Follicular Lymphoma |
73.68
3684%
|
| Title | Percentage of Participants With Objective Response- Intent-to-treat Population: Part 2 (Lead in+ Expanded Cohorts) |
|---|---|
| Description | Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules. |
| Time Frame | Baseline up to 42 days after last dose of study drug (Day 225) |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all enrolled participants. Here 'N' signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study. |
| Arm/Group Title | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts |
|---|---|
| Arm/Group Description | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. |
| Measure Participants | 48 |
| With Diffuse Lymphoma |
15.38
|
| With Follicular Lymphoma |
68.12
|
Adverse Events
| Time Frame | Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study. | |||||||||||||
| Arm/Group Title | Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1 | Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2 | Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3 | Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4 | Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5 | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort | Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort | |||||||
| Arm/Group Description | Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 0.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.34 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 2.4 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. | Participants with CD22-positive B-cell NHL received 1.8 mg/m^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days. | |||||||
All Cause Mortality |
||||||||||||||
| Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1 | Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2 | Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3 | Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4 | Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5 | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort | Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
Serious Adverse Events |
||||||||||||||
| Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1 | Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2 | Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3 | Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4 | Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5 | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort | Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/2 (0%) | 1/5 (20%) | 3/11 (27.3%) | 3/6 (50%) | 4/6 (66.7%) | 0/6 (0%) | 15/43 (34.9%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| THROMBOCYTOPENIA | 0/2 (0%) | 0/5 (0%) | 2/11 (18.2%) | 1/6 (16.7%) | 2/6 (33.3%) | 0/6 (0%) | 3/43 (7%) | |||||||
| LYMPHOMA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| NEUTROPENIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| Cardiac disorders | ||||||||||||||
| DEEP VEIN THROMBOSIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| SYNCOPE | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| LIVER FUNCTION TESTS ABNORMAL | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| VOMITING | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| ANOREXIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/43 (0%) | |||||||
| DIARRHEA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| INTESTINAL OBSTRUCTION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| NAUSEA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| VENOOCCLUSIVE LIVER DISEASE | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| General disorders | ||||||||||||||
| FEVER | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 3/43 (7%) | |||||||
| ASTHENIA | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| ASCITES | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| SEPSIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| BACK PAIN | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| CELLULITIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| CHILLS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/43 (0%) | |||||||
| DEATH | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| HERNIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| MALAISE | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| NEUTROPENIC FEVER | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| PAIN | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| BILIRUBINEMIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| CACHEXIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| LACTIC DEHYDROGENASE INCREASED | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/43 (0%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| ARTHRALGIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| Nervous system disorders | ||||||||||||||
| MENTAL STATUS CHANGES | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| NEUROPATHY | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| SPINAL CORD COMPRESSION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| ACUTE KIDNEY FAILURE | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| PNEUMONIA | 0/2 (0%) | 0/5 (0%) | 2/11 (18.2%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| DYSPNEA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| PLEURAL EFFUSION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| RESPIRATORY FAILURE | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1 | Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2 | Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3 | Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4 | Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5 | Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort | Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/2 (50%) | 5/5 (100%) | 11/11 (100%) | 6/6 (100%) | 6/6 (100%) | 6/6 (100%) | 43/43 (100%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| THROMBOCYTOPENIA | 0/2 (0%) | 3/5 (60%) | 8/11 (72.7%) | 6/6 (100%) | 5/6 (83.3%) | 6/6 (100%) | 38/43 (88.4%) | |||||||
| NEUTROPENIA | 0/2 (0%) | 1/5 (20%) | 3/11 (27.3%) | 2/6 (33.3%) | 3/6 (50%) | 4/6 (66.7%) | 21/43 (48.8%) | |||||||
| ANEMIA | 0/2 (0%) | 0/5 (0%) | 3/11 (27.3%) | 1/6 (16.7%) | 1/6 (16.7%) | 1/6 (16.7%) | 12/43 (27.9%) | |||||||
| LEUKOPENIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 3/6 (50%) | 1/6 (16.7%) | 1/6 (16.7%) | 12/43 (27.9%) | |||||||
| LYMPHOPENIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 1/6 (16.7%) | 1/6 (16.7%) | 2/6 (33.3%) | 6/43 (14%) | |||||||
| ECCHYMOSIS | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 3/43 (7%) | |||||||
| LEUKOCYTOSIS | 0/2 (0%) | 0/5 (0%) | 2/11 (18.2%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 2/43 (4.7%) | |||||||
| FIBRINOGEN INCREASED | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/43 (2.3%) | |||||||
| GRANULOCYTOSIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/43 (2.3%) | |||||||
| INTERNATIONAL NORMALISED RATIO INCREASED | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| LYMPHADENOPATHY | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| LYMPHOMA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| THROMBIN TIME PROLONGED | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/43 (2.3%) | |||||||
| DISSEMINATED INTRAVASCULAR COAGULATION | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| LYMPHOCYTOSIS | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| MEGAKARYOCYTES DECREASED | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| PETECHIAE | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| PURPURA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| RETICULOENDOTHELIAL HYPERPLASIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| SPLENOMEGALY | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| Cardiac disorders | ||||||||||||||
| HEMORRHAGE | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| HYPOTENSION | 0/2 (0%) | 0/5 (0%) | 2/11 (18.2%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| EXTRASYSTOLES | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| HYPERTENSION | 0/2 (0%) | 1/5 (20%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| TACHYCARDIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| VASODILATATION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| ANGINA PECTORIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| ARRHYTHMIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| ATRIAL FIBRILLATION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| BUNDLE BRANCH BLOCK | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| MIGRAINE | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| MYOCARDIAL ISCHEMIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| PALLOR | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| PERIPHERAL VASCULAR DISORDER | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| PHLEBITIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| POSTURAL HYPOTENSION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| SHOCK | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| SUPRAVENTRICULAR EXTRASYSTOLES | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| SYNCOPE | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| VASCULAR ANOMALY | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| VASCULAR DISORDER | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| VASCULITIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| Eye disorders | ||||||||||||||
| CONJUNCTIVITIS | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 1/43 (2.3%) | |||||||
| ABNORMAL VISION | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| EYE DISORDER | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| DRY EYES | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/43 (2.3%) | |||||||
| CATARACT SPECIFIED | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| CORNEAL LESION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| EYE PAIN | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| NAUSEA | 1/2 (50%) | 3/5 (60%) | 6/11 (54.5%) | 4/6 (66.7%) | 2/6 (33.3%) | 4/6 (66.7%) | 20/43 (46.5%) | |||||||
| ANOREXIA | 0/2 (0%) | 2/5 (40%) | 3/11 (27.3%) | 1/6 (16.7%) | 3/6 (50%) | 3/6 (50%) | 12/43 (27.9%) | |||||||
| CONSTIPATION | 0/2 (0%) | 2/5 (40%) | 3/11 (27.3%) | 1/6 (16.7%) | 1/6 (16.7%) | 2/6 (33.3%) | 10/43 (23.3%) | |||||||
| DIARRHEA | 0/2 (0%) | 2/5 (40%) | 0/11 (0%) | 2/6 (33.3%) | 3/6 (50%) | 1/6 (16.7%) | 8/43 (18.6%) | |||||||
| VOMITING | 0/2 (0%) | 1/5 (20%) | 3/11 (27.3%) | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) | 10/43 (23.3%) | |||||||
| GAMMA GLUTAMYL TRANSPEPTIDASE INCREASED | 0/2 (0%) | 0/5 (0%) | 3/11 (27.3%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 4/43 (9.3%) | |||||||
| ABDOMINAL DISTENSION | 0/2 (0%) | 0/5 (0%) | 2/11 (18.2%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 6/43 (14%) | |||||||
| DRY MOUTH | 0/2 (0%) | 2/5 (40%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 3/43 (7%) | |||||||
| DYSPEPSIA | 0/2 (0%) | 0/5 (0%) | 3/11 (27.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| STOMATITIS | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 2/43 (4.7%) | |||||||
| LIVER FUNCTION TESTS ABNORMAL | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) | 2/43 (4.7%) | |||||||
| ERUCTATION | 0/2 (0%) | 1/5 (20%) | 1/11 (9.1%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| APHTHOUS STOMATITIS | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| DYSPHAGIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| FLATULENCE | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| GASTROENTERITIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| GASTROESOPHAGEAL REFLUX DISEASE | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| GUM HEMORRHAGE | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| MUCOSITIS | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| BLOOD IN STOOL | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| CHOLELITHIASIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| FECAL INCONTINENCE | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| GASTROINTESTINAL DISORDER | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| HEPATOMEGALY | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| LIVER FATTY DEPOSIT | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| MOUTH ULCERATION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| NAUSEA AND VOMITING | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/43 (0%) | |||||||
| ORAL MONILIASIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| PANCREAS DISORDER | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| RECTAL DISORDER | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| RECTAL HEMORRHAGE | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| General disorders | ||||||||||||||
| ASTHENIA | 1/2 (50%) | 4/5 (80%) | 7/11 (63.6%) | 3/6 (50%) | 4/6 (66.7%) | 2/6 (33.3%) | 30/43 (69.8%) | |||||||
| FEVER | 0/2 (0%) | 0/5 (0%) | 2/11 (18.2%) | 3/6 (50%) | 3/6 (50%) | 4/6 (66.7%) | 17/43 (39.5%) | |||||||
| ABDOMINAL PAIN | 1/2 (50%) | 1/5 (20%) | 5/11 (45.5%) | 4/6 (66.7%) | 2/6 (33.3%) | 1/6 (16.7%) | 14/43 (32.6%) | |||||||
| HEADACHE | 0/2 (0%) | 0/5 (0%) | 4/11 (36.4%) | 3/6 (50%) | 0/6 (0%) | 1/6 (16.7%) | 9/43 (20.9%) | |||||||
| BACK PAIN | 1/2 (50%) | 0/5 (0%) | 5/11 (45.5%) | 0/6 (0%) | 1/6 (16.7%) | 2/6 (33.3%) | 4/43 (9.3%) | |||||||
| PAIN | 0/2 (0%) | 1/5 (20%) | 2/11 (18.2%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 7/43 (16.3%) | |||||||
| CHILLS | 0/2 (0%) | 1/5 (20%) | 1/11 (9.1%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 6/43 (14%) | |||||||
| LAB TEST ABNORMAL | 0/2 (0%) | 0/5 (0%) | 2/11 (18.2%) | 2/6 (33.3%) | 1/6 (16.7%) | 0/6 (0%) | 3/43 (7%) | |||||||
| CHEST PAIN | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 5/43 (11.6%) | |||||||
| INFECTION | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) | 2/43 (4.7%) | |||||||
| ABDOMEN ENLARGED | 0/2 (0%) | 1/5 (20%) | 1/11 (9.1%) | 2/6 (33.3%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| ACCIDENTAL INJURY | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| FLU SYNDROME | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| NECK PAIN | 0/2 (0%) | 0/5 (0%) | 2/11 (18.2%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| ASCITES | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/43 (2.3%) | |||||||
| PELVIC PAIN | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| ALLERGIC REACTION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| FACE EDEMA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| IMMUNOGLOBULINS DECREASED | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| INJECTION SITE REACTION | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| NEOPLASM | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| RADIATION INJURY | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| Investigations | ||||||||||||||
| TASTE PERVERSION | 0/2 (0%) | 1/5 (20%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| EAR PAIN | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| BLEPHARITIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| EAR DISORDER | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| KERATITIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| TASTE LOSS | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| REACTION UNEVALUABLE | 1/2 (50%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| ALLERGIC REACTION OTHER THAN DRUG | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| DEVICE MALFUNCTION | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| SGOT INCREASED | 0/2 (0%) | 0/5 (0%) | 5/11 (45.5%) | 4/6 (66.7%) | 2/6 (33.3%) | 2/6 (33.3%) | 18/43 (41.9%) | |||||||
| ALKALINE PHOSPHATASE INCREASED | 1/2 (50%) | 0/5 (0%) | 4/11 (36.4%) | 2/6 (33.3%) | 1/6 (16.7%) | 2/6 (33.3%) | 11/43 (25.6%) | |||||||
| SGPT INCREASED | 0/2 (0%) | 0/5 (0%) | 4/11 (36.4%) | 3/6 (50%) | 1/6 (16.7%) | 1/6 (16.7%) | 8/43 (18.6%) | |||||||
| BILIRUBINEMIA | 0/2 (0%) | 0/5 (0%) | 3/11 (27.3%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 11/43 (25.6%) | |||||||
| PERIPHERAL EDEMA | 0/2 (0%) | 2/5 (40%) | 3/11 (27.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 10/43 (23.3%) | |||||||
| HYPOKALEMIA | 0/2 (0%) | 1/5 (20%) | 3/11 (27.3%) | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | 6/43 (14%) | |||||||
| LACTIC DEHYDROGENASE INCREASED | 0/2 (0%) | 0/5 (0%) | 4/11 (36.4%) | 2/6 (33.3%) | 2/6 (33.3%) | 0/6 (0%) | 4/43 (9.3%) | |||||||
| HYPOPROTEINEMIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 6/43 (14%) | |||||||
| WEIGHT LOSS | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 2/6 (33.3%) | 2/6 (33.3%) | 3/43 (7%) | |||||||
| HYPERGLYCEMIA | 0/2 (0%) | 1/5 (20%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 3/43 (7%) | |||||||
| DEHYDRATION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 4/43 (9.3%) | |||||||
| HYPERURICEMIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 4/43 (9.3%) | |||||||
| CREATININE INCREASED | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 3/43 (7%) | |||||||
| EDEMA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/43 (2.3%) | |||||||
| HYPERCHOLESTEREMIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| HYPONATREMIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| BUN INCREASED | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| HYPERCALCEMIA | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| HYPOPHOSPHATEMIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| ACIDOSIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| CACHEXIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| HYPERCHLOREMIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| HYPERLIPEMIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| HYPOCALCEMIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| HYPOCHLOREMIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| HYPOGLYCEMIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| HYPOMAGNESEMIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| WEIGHT GAIN | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| ARTHRALGIA | 1/2 (50%) | 1/5 (20%) | 3/11 (27.3%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 6/43 (14%) | |||||||
| MYALGIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| BONE PAIN | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| MYASTHENIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| JOINT DISORDER | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| MUSCLE ATROPHY | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| MUSCLE CRAMP | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| MUSCLE SPASMS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| MUSCULOSKELETAL STIFFNESS | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| TENDON DISORDER | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| TENOSYNOVITIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| Nervous system disorders | ||||||||||||||
| DIZZINESS | 0/2 (0%) | 1/5 (20%) | 2/11 (18.2%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 5/43 (11.6%) | |||||||
| PARESTHESIA | 0/2 (0%) | 1/5 (20%) | 2/11 (18.2%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 4/43 (9.3%) | |||||||
| INSOMNIA | 0/2 (0%) | 2/5 (40%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 3/43 (7%) | |||||||
| ANXIETY | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 4/43 (9.3%) | |||||||
| DEPRESSION | 0/2 (0%) | 0/5 (0%) | 2/11 (18.2%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| NEUROPATHY | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| NERVOUSNESS | 0/2 (0%) | 1/5 (20%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| SOMNOLENCE | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| AGITATION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| APHASIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| ATAXIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| CLONUS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| FACIAL PARALYSIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| HYPESTHESIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| MENTAL STATUS CHANGES | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| MYELOPATHY | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| NEUROPATHIC PAIN | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| TREMOR | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| URINARY TRACT INFECTION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 3/43 (7%) | |||||||
| URINARY INCONTINENCE | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| ALBUMINURIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| BREAST PAIN | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| CYSTITIS | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| DYSURIA | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| HEMATURIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| HYDRONEPHROSIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| OLIGURIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| TESTIS DISORDER | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| URINARY FREQUENCY | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| URINARY HESITATION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| URINE ABNORMALITY | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| COUGH INCREASED | 0/2 (0%) | 2/5 (40%) | 3/11 (27.3%) | 0/6 (0%) | 1/6 (16.7%) | 4/6 (66.7%) | 7/43 (16.3%) | |||||||
| EPISTAXIS | 0/2 (0%) | 1/5 (20%) | 2/11 (18.2%) | 2/6 (33.3%) | 0/6 (0%) | 3/6 (50%) | 6/43 (14%) | |||||||
| DYSPNEA | 0/2 (0%) | 2/5 (40%) | 3/11 (27.3%) | 2/6 (33.3%) | 0/6 (0%) | 0/6 (0%) | 6/43 (14%) | |||||||
| RHINITIS | 0/2 (0%) | 1/5 (20%) | 1/11 (9.1%) | 0/6 (0%) | 1/6 (16.7%) | 3/6 (50%) | 7/43 (16.3%) | |||||||
| PHARYNGITIS | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 4/43 (9.3%) | |||||||
| SINUSITIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | 3/43 (7%) | |||||||
| UPPER RESPIRATORY INFECTION | 0/2 (0%) | 1/5 (20%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) | 2/43 (4.7%) | |||||||
| SINUS CONGESTION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 4/43 (9.3%) | |||||||
| PLEURAL EFFUSION | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| PULMONARY PHYSICAL FINDING | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| ATELECTASIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| BRONCHITIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| HEMOPTYSIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/43 (2.3%) | |||||||
| HICCUP | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| VOICE ALTERATION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| ALVEOLITIS | 0/2 (0%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| ASTHMA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| LUNG INFILTRATION NOS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| PLEURAL DISORDER | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| PNEUMONIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| PNEUMONITIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/43 (0%) | |||||||
| PNEUMOTHORAX | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| SPUTUM INCREASED | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| THROAT IRRITATION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||
| RASH | 0/2 (0%) | 1/5 (20%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 3/43 (7%) | |||||||
| SWEATING | 1/2 (50%) | 0/5 (0%) | 1/11 (9.1%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 3/43 (7%) | |||||||
| ERYTHEMA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 3/43 (7%) | |||||||
| NIGHT SWEATS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| PRURITUS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 3/43 (7%) | |||||||
| HERPES SIMPLEX | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/43 (4.7%) | |||||||
| HERPES ZOSTER | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/43 (2.3%) | |||||||
| DRY SKIN | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/43 (0%) | |||||||
| ECZEMA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
| FOLLICULITIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| FUNGAL DERMATITIS | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/43 (0%) | |||||||
| PRURITIC RASH | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| SKIN BENIGN NEOPLASM | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| SKIN DISCOLORATION | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/43 (2.3%) | |||||||
| URTICARIA | 0/2 (0%) | 0/5 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/43 (0%) | |||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00073749
Other Study ID Numbers:
- 3129K1-100
- B1931002
First Posted:
Dec 5, 2003
Last Update Posted:
Dec 17, 2018
Last Verified:
Dec 1, 2018