HOUSEHOLD CHARACTERISTICS ER EROCCUR Has the Malaria Control Program performed Indoor Residual Insecticide Spraying (IRS) of your home in the last 12 months? ERTERM= Indoor residual insecticide spraying; EREVLINT=-P12M Yes No Did you sleep under an insecticide treated bed-net last night? ERTERM=Sleep under an insecticide treated bed-net; EREVINTX=LAST NIGHT Yes No HIV STATUS LB Was HIV status collected for this study? LBYN Yes No HIV status at enrolment LBORRES where LBTESTCD=HIV Positive Negative Unknown How was HIV status at enrolment determined? LBMETH Self-report HIV laboratory test If HIV positive, date of last CD4 where LBTESTCD= CD4 CD4 abs. LBORRES LBTESTCD=CD4 and LBORRESU=/uL CD4 % LBORRES where LBTESTCD=CD4 and LBORRESU=% If HIV positive, date of last load LBDTC where LBTESTCD=RNA and LBCAT=VIRAL LOAD and NHOID=HUMAN IMMUNODEFICIENCY VIRUS Viral load result LBORRES where LBTESTCD Viral load units LBORRESU where LBTESTCD =HIVVL |__|__|-|__|__|__|-|__|__|__|__| % |__|__|-|__|__|__|-|__|__|__|__| UNK UNK UNK
HEENT HEENT_PETEST Normal Abnormal HEENT_PEORRES HEENT_PESTAT HEENT_PEREASND Gastrointestinal GI_PETEST Normal Abnormal GI_PEORRES GI_PESTAT GI_PEREASND Joints JOINT_PETEST Normal Abnormal JOINT_PEORRES JOINT_PESTAT JOINT_PEREASND Skin SKIN_PETEST Normal Abnormal SKIN_PEORRES SKIN_PESTAT SKIN_PEREASND Respiratory RESP_PETEST Normal Abnormal RESP_PEORRES RESP_PESTAT RESP_PEREASND Cardiovascular CV_PETEST Normal Abnormal CV_PEORRES CV_PESTAT CV_PEREASND Neurological NEURO_PETEST Normal Abnormal NEURO_PEORRES NEURO_PESTAT NEURO_PEREASND
VISIT 1 MALARIA DIAGNOSTIC TEST LB Was malaria RDT performed? MBPERFYN Yes No NA Date MBDTC |__|__|-|__|__|__|-|__|__|__|__| Time MBTIM MBDTC |__|__|:|__|__| Test type MBTESTCD/MBTEST Lot number DIVAL when DIPARM=Lot Trade name DIVAL when DIPARM=Trade Name Result MBORRES Not done MBSTAT Reason not done MBREASND Pf Pf+Pan Pan Other If other, specify ______________________ MBTESTOTH Positive Negative Invalid MICROSCOPY MBCAT = MALARIA MICROSCOPY REPEAT AS PER PROTOCOL Collection date and time MBDTC Reader number MBEVALID Slide quality SDQUAL type MBMETHOD Parasite type MBTESTCD/ TEST Parasite MBORRES Parasite count units MBORRESU Malaria species MBTESTCD/TEST |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| MBTIM MBDTC Good Poor Missing Thick smear Thin smear Asexual Sexual |__|__|__|__| /_____WBC /_____HPF /_____RBC Pf Pv Po Pm Pk |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| MBTIM MBDTC Good Poor Missing Thick smear Thin smear Asexual Sexual |__|__|__|__| /_____WBC /_____HPF /_____RBC Pf Pv Po Pm Pk
Bilirubinuria Dipstix BILI_LBORRES PREGNANCY LBCAT=PREGNANCY Was a sample taken for pregnancy testing? LBPREFYN Yes No NA76 Date and time of sample |__|__|-|__|__|__|-|__|__|__|__| LBDTC |__|__|:|__|__| LBTIM LBDTC Pregnancy test name LBTEST Results LBORRES Method LBMETH Not done LBSTAT Reason not done LBREASND
ADVERSE EVENTS (AE) (make multiple copies of this page if necessary) Any AEs? AEYN Yes No What is the AE term? AETERM AE number AESPID Start date/time |__|__|-|__|__|__|-|__|__|__|__| AESTDAT AESTDTC End date/time |__|__|-|__|__|__|-|__|__|__|__| AEENDAT AEENDTC Ongoing? AEONGO MHENRTPT/MHENRF |__|__|:|__|__| AESTTIM AESTDTC |__|__|:|__|__| AEENTIM AEENDTC Toxicity grade AETOXGRV Mild AETOXGRV4_1 Moderate AETOXGRV4_2 Severe AETOXGRV4_3 Life threatening AETOXGRV4_4 Fatal7979 AETOXGRV4_5 Outcome Recovered/ Resolved Recovering/ Resolving with sequelae Recovering/ Resolving Not recovered/ Not resolved Fatal Unknown Relationship to study treatment AEREL Not related Unlikely related Possibly related Probably related Definitely related If AE related to study treatment, specify IP Action taken with study treatment AEACN Drug withdrawn Dose reduced Dose not changed Unknown NA Other If other, specify AEACNOTH Other action taken AEACNOTH Yes No Describe other action taken Is the AE serious AESER Yes No Is this a special interest AE? AESI Yes No Was the AE expected? AEEXP Yes No Give description of the AE SERIOUS ADVERSE EVENTS – REPEAT AS REQUIRED
SAE Classification Fatal AESDTH Life threatening AESLIFE Requires or prolongs hospitalization AESHOSP Results in permanent or significant disability/incapacity AESDISAB Congenital anomaly/birth defect AESCONG Medically significant AESMIE Describe medically significant condition: ________________________________________ If hospitalization/ prolonged hospitalization give admission date HOSTDAT where HOTERM = HOSPITALIZATION If hospitalization/prolonged hospitalization give discharge date HOENDAT where HOTERM = HOSPITALIZATION |__|__|-|__|__|__|-|__|__|__|__| Give short description of the SAE CONCOMITANT MEDICATION CM Was any medication given? CMYN Yes No Medication CMTRT daily dose CMDOSTOT Taken prior to study? CMPRIOR Units CMDOSU Route of administration CMROUTE Start date CMSTDAT CMSTDTC Start time CMTIM CMSTDTC End date CMENDAT CMENDTC End time CMENTIM CMENDTC Indication CMINDC Yes mg mL PO IV IM |__|__|-|__|__|__|-|__|__|__|__| |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| |__|__|:|__|__| No tsp TABLET SC TOP PR Ongoing? CMONGO CMENRTPT/CMENRF Yes mg mL PO IV IM |__|__|-|__|__|__|-|__|__|__|__| |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| |__|__|:|__|__|
|__|__|:|__|__| D1H6 S02 Capillary plasma Venous plasma Whole blood Venous Capillary blood Dried Dried Dried APPENDIX D G6PD LBTEST = LB Was a sample for G6PD testing taken? LBPERF Yes No NA Collection date Collection time Test category LBMTHCAT Test type DIVAL where DIPARM=Device type Trade name DIVAL when DIPARM=Trade Name Sample type LBSPEC Sample condition LBSPCCND Result LBORRES Units LBORRESU Not done LBSTAT Reason not done LBREASND |__|__|-|__|__|__|-|__|__|__|__| LBDTC |__|__|:|__|__| LBTIM LBDTC Qualitative Fluorescence spot test RDT Other Whole blood Dried Normal Deficient Invalid Other specify |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| Quantitative Spectrophotometry Biosensor WST 8/1 assay Other
Other specify APPENDIX E CYP 2D6 GENOTYPING PFCAT=GENETIC VARIATION PFSCAT=GENOTYPE PF Was CYP 2D6 Genotyping performed? PFPERF Yes No NA Test type PFTEST Gene location Date of sample PFDAT PFDTC Sample type PFSPEC Sample condition PFSPCCND Not done PFSTAT Reason not done PFREASND Genotype CYP 2D6 |__|__|-|__|__|__|-|__|__|__|__| Whole blood APPENDIX F ECG RECORDING Was the ECG recorded? EGPERF Yes No NA Date of ECG EGDAT EGDTC Time of ECG EGTIM EGDTC Method EGMETHOD Position EGPOS Not done EGSTAT Reason not done EGREASND
|__|__|-|__|__|__|-|__|__|__|__| 12 Lead standard 12-LEAD STANDARD Sitting SITTING Standing STANDING Supine SUPINE |__|__|:|__|__| ECG TEST RESULTS ECG test name EGTEST Results EGORRES Units EGORRESU Not done EGSTAT Reason not done EGREASND RR-interval |__|__|__|__| RRMEAN_EGORRES MSEC PR-interval |__|__|__| PRMEAN_EGORRES MSEC QT-interval |__|__|__| QTMEAN_EGORRES MSEC QRS-duration |__|__|__| QRSDUR_EGORRES MSEC APPENDIX G MEAL RECORD ML Was detailed meal record information collected? MLPERF Yes No NA Date of meal MLDAT MLDTC Start time MLSTTIM MLSTDTC End time MLENTIM MLENDTC Meal type MLTRT Amount consumed MLDOSTXT Amount of fat (gms) FAORRES FATEST = Amount of Fat and FAORRESU = g Not done MLSTAT Reason not done MLREASND